A Phase 1b Study of the Multi-Kinase Inhibitor Regorafenib in Combination With the BCL-2 Inhibitor Venetoclax Plus Azacitidine in Patients With Relapsed/Refractory Acute Myeloid Leukemia

This phase Ib trial tests the safety, side effects, best dose and effectiveness of regorafenib in combination with venetoclax and azacitidine in treating patients with acute myeloid leukemia (AML) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Regorafenib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps to slow or stop the spread of cancer cells. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking BCL-2, a protein needed for cancer cell survival. Azacitidine is in a class of medications called demethylation agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells. Giving regorafenib in combination with venetoclax and azacitidine may be safe, tolerable and/or effective in treating patients with relapsed or refractory AML.

Start Date20 Mar 2025

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

NCT06682611 / Not yet recruitingPhase 1/2

An, Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of SYHA1813 Single Agent or in Combination With Different Regimens in Unresectable Locally Advanced or Metastatic Solid Tumors.

This is an open-label, multi-center, multi-cohort, phase Ib/II clinical trial, divided into 8 cohorts according to tumor types. Cohorts 1-4 are SYHA1813 combined with different regimens, including safety run-in stage and cohort expansion stage. Cohorts 5-8 are SYHA1813 monotherapy and only include the expansion cohorts. The primary objective was to evaluate the safety and efficacy of SYHA1813 single agent or in combination with different regimens in unresectable locally advanced or metastatic solid tumors.

Start Date13 Nov 2024

Sponsor / Collaborator

Shanghai Runshi Pharmaceutical Technology Co., Ltd.

NCT06575725 / Not yet recruitingPhase 2IIT

A Phase 2 Study of Botensilimab, Balstilimab and Regorafenib in Patients With Microsatellite Stable Colorectal Cancer

This phase II trial studies how well the combination of botensilimab, balstilimab and regorafenib works compared to botensilimab and balstilimab in treating patients with microsatellite stable colorectal cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as botensilimab and balstilimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Regorafenib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals tumor cells to multiply. This helps to slow or stop the spread of tumor cells. The combination of botensilimab, balstilimab and regorafenib or botensilimab and balstilimab may be a safe and effective treatment for advanced or metastatic microsatellite stable colorectal cancer.

Start Date01 Nov 2024

Sponsor / Collaborator

Hope Medical Center

[+1]

100 Clinical Results associated with Regorafenib

100 Translational Medicine associated with Regorafenib

100 Patents (Medical) associated with Regorafenib

1,875

Literatures (Medical) associated with Regorafenib

31 Dec 2024·JOURNAL OF MEDICAL ECONOMICS

Budget impact analysis of introducing fruquintinib for metastatic colorectal cancer previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy and biologics in the United States from the payer perspective

Article

Author: Asfaw, Alemseged Ayele ; Hernandez, Luis ; Li, Shujun ; Zou, Denise ; Khanduri, Pratishtha ; Paly, Victoria Federico

AIMS:

Fruquintinib is a selective small molecule tyrosine kinase inhibitor of vascular endothelial growth factor receptor (VEGFR)-1, -2, and -3 recently approved in the United States (US) for the treatment of adult patients with metastatic colorectal cancer (CRC) who have previously been treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type and medically appropriate, anti-epidermal growth factor receptor therapy. This study aimed to estimate the 5-year budget impact of fruquintinib from a US payer perspective (commercial and Medicare).

MATERIALS AND METHODS:

A budget impact model was developed to compare two scenarios: a reference scenario in which patients received regorafenib, trifluridine/tipiracil, or trifluridine/tipiracil with bevacizumab and an alternative scenario in which patients received reference scenario treatments or fruquintinib. Market shares were evenly divided across available options. A 5-year time horizon and a hypothetical health plan of 1 million members was assumed. The model included epidemiological inputs to estimate the eligible population; clinical inputs for treatment duration, progression-free survival, overall survival, and adverse event (AE) frequency; and cost inputs for treatment, AEs, disease management, subsequent therapy, and terminal care costs. Budget impact was reported as total, per member per year (PMPY), and per member per month (PMPM).

RESULTS:

The model estimated an eligible population of 194 patients (39 per year) over 5 years. In the base case, the estimated 5-year budget impact of fruquintinib was $4,077,073 ($0.82 PMPY and 0.07 PMPM) for a commercial health plan. During the first year, the estimated budget impact was $627,570 ($0.63 PMPY and 0.05 PMPM). Results were robust across sensitivity analyses. PMPM costs from the Medicare perspective were greater than the base-case (commercial) ($0.17 vs. $0.07) due to higher incidence of CRC in that population.

CONCLUSIONS:

Fruquintinib is associated with a low budget impact for payers based on proposed thresholds in the US.

01 Dec 2024·LIFE SCIENCES

Integration of network pharmacology, metabolomics and lipidomics for clarifying the role of sphingolipid metabolism in the treatment of liver cancer by regorafenib

Article

Author: Hu, Chunxiu ; Hu, Jinlong ; Lin, Zhikun ; Wei, Letian ; Cui, Shimeng ; Liu, Wenru ; Zhong, Rui ; Tan, Guang ; Li, Qi ; Wang, Xiaolin ; Geng, Pengyu ; Mu, Hua ; Xu, Guowang

AIMS:

Regorafenib, an FDA-approved drug for advanced primary liver cancer (PLC), could provide survival benefits for patients. However, markers for its therapeutic sensitivity are lacking. This study seeks to identify sensitive targets of regorafenib in PLC from the perspective of small molecular metabolites.

MATERIALS AND METHODS:

Initiated with network pharmacology (NP) to map regorafenib's target landscape and metabolic regulatory network in liver cancer. Subsequently, regorafenib's impact on hepatoma cells was evaluated by flow cytometry, western blotting (WB) and cell viability assay. Advanced metabolomics and lipidomics were employed to elucidate regorafenib's metabolic reprogramming effects in liver cancer. Metabolic enzyme expression was assessed by WB, immunohistochemical and immunofluorescence assays. Ultimately, mendelian randomization (MR) analysis was utilized to investigate the potential causality of sphingolipid metabolism in hepatic cancer.

KEY FINDINGS:

Regorafenib was observed to inhibit hepatoma cell proliferation and cell cycle progression at G0/G1 phase, resulting in significant alterations in sphingolipid levels. It promoted the significant accumulation of 16:0 dihydroceramide (16:0 dhCer) by upregulating ceramide synthase 6 (CERS6) expression and inhibiting dihydroceramide desaturase 1 (DEGS1) activity. The MR analysis revealed that DEGS1 was a risk factor for the development and progression of liver cancer, while cumulative 16:0 dhCer was a protective factor.

SIGNIFICANCE:

Sphingolipids, particularly dhCer and regulatory enzymes, may be potential sensitive markers of regorafenib in the treatment of liver cancer, providing new insights for enhancing the treated efficacy of regorafenib in liver cancer.

01 Dec 2024·EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

In vitro assessment of inhibitory effects of kinase inhibitors on CYP2C9, 3A and 1A2: Prediction of drug-drug interaction risk with warfarin and direct oral anticoagulants

Article

Author: Cai, Weimin ; Kurkela, Mika ; Backman, Janne T ; Jin, Shasha ; Backman, Janne T. ; Xiang, Xiaoqiang ; Neuvonen, Mikko ; Kahma, Helinä ; Paludetto, Marie-Noëlle

OBJECTIVE:

This study aimed to evaluate the cytochrome P450 (CYP)-mediated drug-drug interaction (DDI) potential of kinase inhibitors with warfarin and direct oral anticoagulants (DOACs).

METHODS:

An in vitro CYP probe substrate cocktail assay was used to study the inhibitory effects of fifteen kinase inhibitors on CYP2C9, 3A, and 1A2. Then, DDI predictions were performed using both mechanistic static and physiologically-based pharmacokinetic (PBPK) models.

RESULTS:

Linsitinib, masitinib, regorafenib, tozasertib, trametinib, and vatalanib were identified as competitive CYP2C9 inhibitors (K_i = 1.4, 1.0, 1.1, 3.8, 0.5, and 0.1 μM, respectively). Masitinib and vatalanib were competitive CYP3A inhibitors (K_i = 1.3 and 0.2 μM), and vatalanib noncompetitively inhibited CYP1A2 (K_i = 2.0 μM). Moreover, linsitinib and tozasertib were CYP3A time-dependent inhibitors (K_I = 26.5 and 400.3 μM, k_inact = 0.060 and 0.026 min^-1, respectively). Only linsitinib showed time-dependent inhibition of CYP1A2 (K_I = 13.9 μM, k_inact = 0.018 min^-1). Mechanistic static models identified possible DDI risks for linsitinib and vatalanib with (S)-/(R)-warfarin, and for masitinib with (S)-warfarin. PBPK simulations further confirmed that vatalanib may increase (S)- and (R)-warfarin exposure by 4.37- and 1.80-fold, respectively, and that linsitinib may increase (R)-warfarin exposure by 3.10-fold. Mechanistic static models predicted a smaller risk of DDIs between kinase inhibitors and apixaban or rivaroxaban. The greatest AUC increases (1.50-1.74) were predicted for erlotinib in combination with apixaban and rivaroxaban. Linsitinib, masitinib, and vatalanib were predicted to have a smaller effect on apixaban and rivaroxaban AUCs (AUCR 1.22-1.53). No kinase inhibitor was predicted to increase edoxaban exposure.

CONCLUSIONS:

Our results suggest that several kinase inhibitors, including vatalanib and linsitinib, can cause CYP-mediated drug-drug interactions with warfarin and, to a lesser extent, with apixaban and rivaroxaban. The work provides mechanistic insights into the risk of DDIs between kinase inhibitors and anticoagulants, which can be used to avoid preventable DDIs in the clinic.

News (Medical) associated with Regorafenib

06 Nov 2024

·www.businesswire.com

Arcus Biosciences Reports Third-Quarter 2024 Financial Results and Provides a Pipeline Update

HAYWARD, Calif.--( BUSINESS WIRE )--Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for patients with cancer, today reported financial results for the third quarter ended September 30, 2024, and provided a pipeline update on its clinical-stage investigational molecules — targeting TIGIT, HIF-2a, CD73, the A2a/A2b receptors, CD-39, AXL and PD-1 — across multiple common cancers. “ Through the course of this year, we have presented multiple compelling datasets at medical conferences that we believe have de-risked several programs and support potential best-in-class profiles for our molecules, including our HIF-2a inhibitor casdatifan in ccRCC and our Fc-silent anti-TIGIT antibody domvanalimab in lung and upper gastrointestinal cancers,” said Terry Rosen, Ph.D., chief executive officer of Arcus. “ Meanwhile, in addition to our rapidly approaching first Phase 3 readout for domvanalimab in gastric cancer, we are aggressively pursuing our development plan for casdatifan, including in the IO-naive ccRCC setting in collaboration with AstraZeneca, and in the post-IO setting with the initiation of our Phase 3 PEAK-1 study in the first half of next year.” Corporate Updates: In October 2024, Arcus announced a clinical collaboration with AstraZeneca to evaluate casdatifan in combination with volrustomig, AstraZeneca’s investigational PD-1/CTLA-4 bispecific antibody, in IO-naive patients with ccRCC. AstraZeneca will operationalize the study. This is the second clinical collaboration between Arcus and AstraZeneca. Gilead retains the right to opt in to the development and commercialization for casdatifan after delivery of a qualifying data package. Pipeline Highlights: Casdatifan (HIF-2a inhibitor) Casdatifan Updates: First clinical data from the casdatifan 100mg and 50mg expansion cohorts of ARC-20, a Phase 1/1b study in metastatic ccRCC, were presented in an oral plenary session at the 2024 EORTC-NCI-AACR Symposium in October. Observations from the 100mg daily expansion cohort included: An objective response rate (ORR) of 34% (2 responses are pending confirmation; 25% confirmed ORR), a low rate of primary progression of 19% and a high disease control rate of 81%. The median progression-free survival (PFS) had not been reached at the time of the data cutoff. Together, these data support the potential for casdatifan to be a best-in-class HIF-2a inhibitor for the treatment of ccRCC. In the third quarter, Arcus had a successful Type B meeting with the U.S. Federal Drug Administration (FDA) to discuss its first Phase 3 study for casdatifan, PEAK-1, which will evaluate casdatifan in combination with cabozantinib versus cabozantinib in post-IO patients with ccRCC. Arcus is moving rapidly toward the initiation of PEAK-1 in the first half of 2025. Upcoming Casdatifan Milestones: Multiple expansion cohorts of ARC-20 evaluating casdatifan in ccRCC as a monotherapy and in combination with cabozantinib in ccRCC are underway with additional data presentations expected in the next 12 months. 100mg (50mg twice daily (BID), capsules) and 50mg expansion cohorts: Updated data, including median PFS, are expected to be presented in the first quarter of 2025. 150mg and 100mg (once daily (QD), tablets) expansion cohorts: Initial data are expected to be presented in 2025. 100mg of casdatifan plus cabozantinib: Safety data are expected to be presented in 2025. Domvanalimab (Fc-silent anti-TIGIT antibody) plus Zimberelimab (anti-PD-1 antibody) Domvanalimab-Zimberelimab Updates: Data from Part 1 of ARC-10, a randomized study evaluating domvanalimab plus zimberelimab in PD-L-1 high NSCLC are being presented at the SITC Annual Meeting in November. Domvanalimab plus zimberelimab was associated with greater PFS, overall survival, and objective response rate compared with zimberelimab or chemotherapy. A 36% reduction in risk of death (hazard ratio [HR]=0.64) was observed for domvanalimab plus zimberelimab compared to that of zimberelimab alone. Zimberelimab reached a median overall survival of 2 years, and the median overall survival for domvanalimab plus zimberelimab was not reached. Treatment-related adverse events leading to treatment discontinuation were low (10.5%) for the combination of domvanalimab and zimberelimab. Data from an investigator-sponsored trial evaluating domvanalimab plus zimberelimab in anti-PD-(L)1 refractory hepatocellular carcinoma will be presented in an oral session at the SITC Annual Meeting. Upcoming Domvanalimab-Zimberelimab Milestones: Overall survival data from the Phase 2 EDGE-Gastric study, evaluating domvanalimab plus zimberelimab and chemotherapy in upper gastrointestinal (GI) adenocarcinomas, are expected to be presented in 2025. CD73-Adenosine Axis: Quemliclustat (small-molecule CD73 inhibitor) and Etrumadenant (A2a/A2b receptor antagonist) Quemliclustat Arcus has initiated PRISM-1, a Phase 3 trial of quemliclustat combined with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel in pancreatic cancer. Etrumadenant Biomarker data from cohort B of ARC-9, a randomized Phase 1b/2 study evaluating etrumadenant plus zimberelimab, FOLFOX chemotherapy and bevacizumab (EZFB) versus regorafenib in third-line metastatic colorectal cancer (mCRC), are being presented at SITC in November. Early Clinical Programs Evaluation of AB801, a potent and highly selective small-molecule AXL inhibitor, in the dose-escalation phase of a Phase 1/1b study in patients is ongoing. Arcus anticipates advancing this molecule into expansion cohorts in NSCLC in early 2025. Financial Results for Third Quarter 2024: Cash, Cash Equivalents and Marketable Securities were $1.1 billion as of September 30, 2024, compared to $866 million as of December 31, 2023. The increase during the period is primarily due to the receipt of $320 million in cash from Gilead for their January 2024 equity investment, the receipt of the $100 million option continuation payment from Gilead in July 2024 and proceeds from our $50 million term loan, partially offset by the use of cash in research and development activities. We believe our cash, cash equivalents and marketable securities on-hand will be sufficient to fund operations into mid-2027. Cash, cash equivalents and marketable securities are expected to be between $950 million and $985 million at the end of 2024. Revenues were $48 million for the third quarter 2024, compared to $32 million for the same period in 2023. In the third quarter 2024, Arcus recognized $41 million in license and development services revenue related to the advancement of programs and Taiho's exercise of its option for the license of quemliclustat for the Taiho Territory of $15 million, as well as $7 million in other collaboration revenue primarily related to Gilead’s ongoing rights to access Arcus’s research and development pipeline in accordance with the Gilead collaboration agreement. Research and Development (R&D) Expenses were $123 million for the third quarter 2024, compared to $82 million for the same period in 2023. The net increase of $41 million was primarily driven by higher clinical trial and headcount-related costs associated with our late-stage development program activities. Non-cash stock-based compensation expense was $9 million for the third quarter 2024, compared to $8 million for the same period in 2023. For the third quarter 2024 and 2023, Arcus recognized gross reimbursements of $37 million and $33 million, respectively, for shared expenses from its collaborations, primarily the Gilead collaboration. R&D expense by quarter may fluctuate due to the timing of clinical manufacturing and standard-of-care therapeutic purchases with a corresponding impact on reimbursements. General and Administrative (G&A) Expenses were flat for the third quarter 2024, compared to the same period in 2023. Non-cash stock-based compensation expense was $10 million for each of the third quarter 2024 and 2023. Net Loss was $92 million for the third quarter 2024, compared to $71 million for the same period in 2023. Conference Call Information: Arcus will host a conference call and webcast today, November 6, at 2:00 PM PT/5:00 PM ET to discuss its third-quarter 2024 financial results and pipeline updates. To access the call, please dial +1 (404) 975-4839 (local) or +1 (833) 470-1428 (toll-free), using Access Code: 940081. Participants may also register for the call online using the following link: https://www.netroadshow.com/events/login?show=4818aee3&confId=72838 . To access the live webcast and accompanying slide presentation, please visit the “Investors & Media” section of the Arcus Biosciences website at www.arcusbio.com . A replay of the webcast will be available following the live event. Arcus Ongoing and Announced Clinical Studies: Trial Name Arms Setting Status NCT No. Lung Cancer STAR-121 dom + zim + chemo vs. pembro + chemo 1L NSCLC (PD-L1 all-comers) Ongoing Registrational Phase 3 NCT05502237 PACIFIC-8 dom + durva vs. durva Unresectable Stage 3 NSCLC Ongoing Registrational Phase 3 NCT05211895 ARC-7 zim vs. dom + zim vs. etruma + dom + zim 1L NSCLC (PD-L1 ≥ 50%) Ongoing Randomized Phase 2 NCT04262856 EDGE-Lung dom +/- zim +/- quemli +/- chemo 1L/2L NSCLC (lung cancer platform study) Ongoing Randomized Phase 2 NCT05676931 VELOCITY-Lung dom +/- zim +/- etruma +/- sacituzumab govitecan-hziy or other combos 1L/2L NSCLC (lung cancer platform study) Ongoing Randomized Phase 2 NCT05633667 Upper Gastrointestinal Cancers STAR-221 dom + zim + chemo vs. nivo + chemo 1L Gastric, GEJ and EAC Ongoing Registrational Phase 3 NCT05568095 EDGE-Gastric (ARC-21) dom +/- zim +/- quemli +/- chemo 1L/2L Upper GI Malignancies Ongoing Randomized Phase 2 NCT05329766 Colorectal Cancer ARC-9 etruma + zim + mFOLFOX vs. SOC 2L/3L/3L+ CRC Ongoing Randomized Phase 2 NCT04660812 Pancreatic Cancer PRISM-1 quemli + gem/nab-pac vs. gem/nab-pac 1L PDAC Ongoing Phase 3 NCT06608927 ARC-8 quemli + zim + gem/nab-pac vs. quemli + gem/nab-pac 1L, 2L PDAC Ongoing Randomized Phase 1/1b NCT04104672 Kidney Cancer PEAK-1 cas + cabo vs. cabo Post-IO ccRCC Planned Phase 3 TBD ARC-20 cas, cas + cabo Cancer Patients/ccRCC Ongoing Phase 1/1b NCT05536141 Other ARC-25 AB598 Advanced Malignancies Ongoing NCT05891171 ARC-27 AB801 Advanced Malignancies Ongoing NCT06120075 cabo: cabozantinib; cas: casdatifan; dom: domvanalimab; durva: durvalumab; etruma: etrumadenant; gem/nab-pac: gemcitabine/nab-paclitaxel; nivo: nivolumab; pembro: pembrolizumab; quemli: quemliclustat; SOC: standard of care; zim: zimberelimab; ccRCC: clear cell renal cell carcinoma; CRC: colorectal cancer; EAC: esophageal adenocarcinoma; GEJ: gastroesophageal junction; GI: gastrointestinal; NSCLC: non-small cell lung cancer; PDAC: pancreatic ductal adenocarcinoma About the Gilead Collaboration In May 2020, Arcus established a 10-year collaboration with Gilead to strategically advance our portfolio. Under this collaboration, Gilead obtained time-limited exclusive option rights to all of our clinical programs arising during the collaboration term. Arcus and Gilead are co-developing four investigational products, including zimberelimab (Arcus’s anti-PD-1 molecule), domvanalimab (Arcus’s anti-TIGIT antibody), etrumadenant (Arcus’s adenosine receptor antagonist) and quemliclustat (Arcus’s CD73 inhibitor). The collaboration was expanded in November 2021 and May 2023 to include research directed to two targets for oncology and two targets for inflammatory diseases. About Arcus Biosciences Arcus Biosciences is a clinical-stage, global biopharmaceutical company developing differentiated molecules and combination medicines for people with cancer. In partnership with industry collaborators, patients and physicians around the world, Arcus is expediting the development of first- or best-in-class medicines against well-characterized biological targets and pathways and studying novel, biology-driven combinations that have the potential to help people with cancer live longer. Founded in 2015, the company has expedited the development of multiple investigational medicines into clinical studies, including new combination approaches that target TIGIT, PD-1, HIF-2a, CD73, dual A2a/A2b receptor, CD39 and AXL. For more information about Arcus Biosciences’ clinical and preclinical programs, please visit www.arcusbio.com . Domvanalimab, etrumadenant, quemliclustat and zimberelimab are investigational molecules, and neither Gilead nor Arcus has received approval from any regulatory authority for any use globally, and their safety and efficacy have not been established. Casdatifan, AB598 and AB801 are also investigational molecules, and Arcus has not received approval from any regulatory authority for any use globally, and their safety and efficacy have not been established. Forward-Looking Statements This press release contains forward-looking statements. All statements regarding events or results to occur in the future contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, the statements in Dr. Rosen’s quote and statements regarding: Arcus’s expectation that its cash, cash equivalents and marketable securities on-hand are sufficient to fund operations into mid-2027; plans to disclose or present study analyses or data, including any analyses or data from ARC-20 or EDGE-Gastric; whether data and results from studies validate our pipeline or support further development of a program; the potency, efficacy or safety of Arcus’s investigational products, including their potential for a best-in-class profile; and the initiation, design of and associated timing for future studies, including statements about PEAK-1 and PRISM-1. All forward-looking statements involve known and unknown risks and uncertainties and other important factors that may cause Arcus’s actual results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: risks associated with preliminary and interim data not being guarantees that future data will be similar; the unexpected emergence of adverse events or other undesirable side effects in Arcus’s investigational products; difficulties or delays in initiating or conducting clinical trials due to difficulties or delays in the regulatory process, enrolling subjects or manufacturing or supplying product for such clinical trials; unfavorable global economic, political and trade conditions; Arcus’s dependence on the collaboration with third parties such as Gilead and Taiho for the successful development and commercialization of its optioned molecules; difficulties associated with the management of the collaboration activities or expanded clinical programs; changes in the competitive landscape for Arcus’s programs; and the inherent uncertainty associated with pharmaceutical product development and clinical trials. Risks and uncertainties facing Arcus are described more fully in the “Risk Factors” section of Arcus’s most recent periodic report filed with the U.S. Securities and Exchange Commission. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Arcus disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release except to the extent required by law. The Arcus name and logo are trademarks of Arcus Biosciences, Inc. All other trademarks belong to their respective owners. ARCUS BIOSCIENCES, INC. Consolidated Statements of Operations (unaudited) (In millions, except per share amounts) Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 Revenues: License and development services revenue $ 41 $ 22 $ 204 $ 58 Other collaboration revenue 7 10 28 28 Total revenues 48 32 232 86 Operating expenses: Research and development 123 82 347 247 General and administrative 30 30 92 88 Impairment of long-lived assets — — 20 — Total operating expenses 153 112 459 335 Loss from operations (105 ) (80 ) (227 ) (249 ) Non-operating income (expense): Interest and other income, net 14 12 40 30 Interest expense (1 ) (1 ) (2 ) (2 ) Total non-operating income, net 13 11 38 28 Loss before income taxes (92 ) (69 ) (189 ) (221 ) Income tax expense — (2 ) — (5 ) Net loss $ (92 ) $ (71 ) $ (189 ) $ (226 ) Net loss per share: Basic and diluted $ (1.00 ) $ (0.94 ) $ (2.11 ) $ (3.07 ) Shares used to compute net loss per share: Basic and diluted 91.4 74.6 89.6 73.6 Selected Consolidated Balance Sheet Data (unaudited) (In millions) September 30, 2024 December 31, 2023 (1) Cash, cash equivalents and marketable securities $ 1,091 $ 866 Total assets 1,252 1,095 Total liabilities 687 633 Total stockholders’ equity 565 462 (1) Derived from the audited financial statements for the quarter ended December 31, 2023, included in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 21, 2024.

Phase 3Phase 2License out/inFinancial StatementClinical Result

25 Sep 2024

·www.fiercebiotech.com

Merck's Keytruda-LAG-3 combo fails to tame tough colorectal cancer in phase 3

Despite a setback, Merck's favezelimab still has other shots at coming to market. An attempt by Merck & Co. to unlock the microsatellite stable (MSS) metastatic colorectal cancer market has ended in failure. The drugmaker found a fixed-dose combination of Keytruda and an anti-LAG-3 antibody failed to improve overall survival, extending the wait for a checkpoint inhibitor that moves the needle in the indication.An earlier colorectal cancer study supported full FDA approval of Keytruda in people with microsatellite instability-high solid tumors. MSS colorectal cancer, the most common form of the disease, has proven a tougher nut to crack, with checkpoint inhibitors achieving sub-10% response rates as single agents.The lack of monotherapy efficacy in the setting has fueled interest in combining PD-1/L1 inhibition with other mechanisms of action, including blockade of LAG-3. Binding to LAG-3 could drive the activation of antigen-specific T lymphocytes and the destruction of cancer cells, potentially leading to responses in people who are resistant to anti-PD-1/L1 therapy.Merck put that idea to the test in KEYFORM-007, an open-label trial that pitted the favezelimab-Keytruda combination against the investigator’s choice of regorafenib, which Bayer sells as Stivarga, or trifluridine plus tipiracil. The study combination failed to improve on the survival achieved by the standard of care options, closing off one avenue for bringing checkpoint inhibitors to MSS colorectal cancer. On an earnings call in February, Dean Li, M.D., Ph.D., president of Merck Research Laboratories, said his team would use a positive signal in the favezelimab-Keytruda trial “as a beachhead to expand and extend the role of checkpoint inhibitors in MSS CRC.” That positive signal failed to materialize, but Merck said it will continue to study other Keytruda-based combinations in colorectal cancer.Favezelimab still has other shots at coming to market. Merck’s LAG-3 development program includes a phase 3 trial that is studying the fixed-dose combination in patients with relapsed or refractory classical Hodgkin lymphoma who have progressed on anti-PD-1 therapy. That trial, which is still enrolling, has an estimated primary completion date in 2027.

Phase 3Phase 2

25 Sep 2024

·pipelinereview.com

Merck Provides Update on Phase 3 KEYFORM-007 Trial Evaluating Investigational Fixed-Dose Combination of Favezelimab and Pembrolizumab for Patients With Previously Treated PD-L1 Positive Microsatellite Stable Metastatic Colorectal Cancer

RAHWAY, NJ, USA I September 25, 2024 I Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the Phase 3 KEYFORM-007 trial evaluating the investigational fixed-dose combination of favezelimab, Merck’s anti-LAG-3 antibody, and pembrolizumab (KEYTRUDA ® ), Merck’s anti-PD-1 therapy, did not meet its primary endpoint of overall survival (OS) for the treatment of patients with previously treated PD-L1 positive microsatellite stable (MSS) metastatic colorectal cancer (mCRC). At the final pre-specified analysis, the favezelimab and pembrolizumab fixed-dose combination did not demonstrate an improvement in OS compared to standard of care (regorafenib or TAS-102 [trifluridine and tipiracil hydrochloride]). The safety profile of the fixed-dose combination was consistent with that observed for favezelimab and pembrolizumab in previously reported studies, with no new safety signals observed. A full evaluation of the data is ongoing and Merck will work with investigators to share the results with the scientific community. “Metastatic colorectal cancer continues to be a challenging disease to treat, especially for the majority of patients who have microsatellite stable disease, which has had limited response to immunotherapies,” said Dr. M. Catherine Pietanza, vice president, global clinical development, Merck Research Laboratories. “We are grateful to the patients and investigators for their participation in this study, and we will continue to advance our clinical development program to evaluate KEYTRUDA-based combinations and novel candidates for patients with colorectal cancer in need of new options.” In the U.S., KEYTRUDA is approved for the treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer as determined by an FDA-approved test. KEYTRUDA is not approved for the treatment of MSS mCRC. The favezelimab and pembrolizumab fixed-dose combination is also being evaluated in certain hematologic malignancies and multiple solid tumor types. Ongoing studies include KEYFORM-008 , a Phase 3 study evaluating the fixed-dose combination in patients with relapsed or refractory classical Hodgkin lymphoma whose disease has progressed following prior anti-PD-1 therapy. About KEYFORM-007 KEYFORM-007 is a randomized, open-label Phase 3 trial (ClinicalTrials.gov, NCT05064059 ) evaluating the fixed-dose combination of favezelimab and pembrolizumab (MK-4280A) versus standard of care, regorafenib or TAS-102 (trifluridine and tipiracil), for the treatment of patients with PD-L1 positiveMSS mCRC who were previously treated with standard therapies. The primary endpoint is OS, and key secondary endpoints include progression-free survival, objective response rate, duration of response, safety and quality of life. The trial enrolled 441 patients who were randomized (1:1) to receive: About colorectal cancer Colorectal cancer can be referred to as colon cancer or rectal cancer, depending on where the cancer starts. Colorectal cancer often begins with growths on the inner lining of the colon or rectum called polyps, which can change into cancer over time. Colorectal cancer is the third most commonly diagnosed cancer and the second most common cause of cancer-related death worldwide. It is estimated there were nearly 1.9 million patients diagnosed with colorectal cancer and more than 900,000 patient deaths from the disease globally in 2022. In the United States, it is estimated that there will be approximately 107,000 patients diagnosed with colon cancer and approximately 46,000 patients diagnosed with rectal cancer, resulting in more than 53,000 deaths from colorectal cancer in 2024. The five-year relative survival rates in the U.S. for metastatic colon cancer and rectal cancer (stage IV) are estimated to be 13% and 18%, respectively. About favezelimab Favezelimab (MK-4280) is an investigational anti-lymphocyte activation gene-3 (LAG-3) antibody. LAG-3 is a cell surface immunomodulatory receptor expressed on various immune cells that down-regulates T cell proliferation and activation. Favezelimab aims to restore T cell effector function by preventing LAG-3 from binding to its primary ligand, major histocompatibility complex (MHC) class II molecules. The fixed-dose combination of favezelimab and pembrolizumab (MK-4280A) is being evaluated across multiple solid tumor types and in patients with relapsed or refractory classical Hodgkin lymphoma whose disease has progressed following prior anti-PD-1 therapy. About KEYTRUDA ® (pembrolizumab) injection, 100 mg KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD- L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells. Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,600 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers. Selected KEYTRUDA ® (pembrolizumab) Indications in the U.S. Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-approved test. Melanoma KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma. KEYTRUDA is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection. Non-Small Cell Lung Cancer KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC. KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is: KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. KEYTRUDA is indicated for the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. KEYTRUDA, as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC. Malignant Pleural Mesothelioma KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM). Head and Neck Squamous Cell Cancer KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC). KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test. KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy. Classical Hodgkin Lymphoma KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL). KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy. Primary Mediastinal Large B-Cell Lymphoma KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy. Urothelial Cancer KEYTRUDA, in combination with enfortumab vedotin, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer. KEYTRUDA, as a single agent, is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma: KEYTRUDA, as a single agent, is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. Microsatellite Instability-High or Mismatch Repair Deficient Cancer KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. Gastric Cancer KEYTRUDA, in combination with trastuzumab, fluoropyrimidine- and platinum containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval of this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. KEYTRUDA, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. Esophageal Cancer KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either: Cervical Cancer KEYTRUDA, in combination with chemoradiotherapy (CRT), is indicated for the treatment of patients with FIGO 2014 Stage III-IVA cervical cancer. KEYTRUDA, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. Hepatocellular Carcinoma KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen. Biliary Tract Cancer KEYTRUDA, in combination with gemcitabine and cisplatin, is indicated for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC). Merkel Cell Carcinoma KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). Renal Cell Carcinoma KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). KEYTRUDA is indicated for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. Endometrial Carcinoma KEYTRUDA, in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma. KEYTRUDA, as a single agent, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. Tumor Mutational Burden-High Cancer KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established. Cutaneous Squamous Cell Carcinoma KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation. Triple-Negative Breast Cancer KEYTRUDA is indicated for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test. Merck’s focus on cancer Every day, we follow the science as we work to discover innovations that can help patients, no matter what stage of cancer they have. As a leading oncology company, we are pursuing research where scientific opportunity and medical need converge, underpinned by our diverse pipeline of more than 25 novel mechanisms. With one of the largest clinical development programs across more than 30 tumor types, we strive to advance breakthrough science that will shape the future of oncology. By addressing barriers to clinical trial participation, screening and treatment, we work with urgency to reduce disparities and help ensure patients have access to high-quality cancer care. Our unwavering commitment is what will bring us closer to our goal of bringing life to more patients with cancer. For more information, visit https://www.merck.com/research/oncology . About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter) , Facebook , Instagram , YouTube and LinkedIn . SOURCE: Merck

Phase 3Clinical ResultImmunotherapyAccelerated ApprovalASCO

100 Deals associated with Regorafenib

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KEGG	Wiki	ATC	Drug Bank
-	Regorafenib	L01XE21	DB08896

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Liver Cancer	CN	Bayer AG	05 Dec 2017
Hepatocellular Carcinoma	EU	Bayer Pharma AG	26 Aug 2013
Hepatocellular Carcinoma	IS	Bayer Pharma AG	26 Aug 2013
Hepatocellular Carcinoma	LI	Bayer Pharma AG	26 Aug 2013
Hepatocellular Carcinoma	NO	Bayer Pharma AG	26 Aug 2013
Colorectal Cancer	JP	Bayer Yakuhin Ltd.	25 Mar 2013
Gastrointestinal Stromal Tumors	US	Bayer HealthCare Pharmaceuticals, Inc.	25 Feb 2013
Metastatic Colorectal Carcinoma	US	Bayer HealthCare Pharmaceuticals, Inc.	27 Sep 2012

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Colorectal Liver Metastases	Phase 3	CN	Sun Yat-Sen University	10 Jun 2023
Glioblastoma	Phase 3	DE	Bayer AG	06 Sep 2022
Esophageal Carcinoma	Phase 3	US	Bayer AG	01 Jun 2021
Esophageal Carcinoma	Phase 3	US	Bristol Myers Squibb Co.	01 Jun 2021
Esophageal Carcinoma	Phase 3	JP	Bristol Myers Squibb Co.	01 Jun 2021
Esophageal Carcinoma	Phase 3	JP	Bayer AG	01 Jun 2021
Esophageal Carcinoma	Phase 3	AU	Bristol Myers Squibb Co.	01 Jun 2021
Esophageal Carcinoma	Phase 3	AU	Bayer AG	01 Jun 2021
Esophageal Carcinoma	Phase 3	AT	Bristol Myers Squibb Co.	01 Jun 2021
Esophageal Carcinoma	Phase 3	AT	Bayer AG	01 Jun 2021

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04117945 (CTgov)	Phase 2	Colorectal Cancer, Hereditary Nonpolyposis, Type 1 \| Metastatic Colorectal Carcinoma	22	Regorafenib (Arm A (Regorafenib))	cewuiivdwm(btvkxzujbj) = kojedpzcfn rnayxqgcry (nteldpxyty, aukflvguwi - lgfaorloye) View more	-	27 Sep 2024
				Cetuximab+Irinotecan+Panitumumab (Arm B (Cetuximab, Panitumumab, Irinotecan))	cewuiivdwm(btvkxzujbj) = pdkrivzqec rnayxqgcry (nteldpxyty, jjqnaupris - ptubyrzoji) View more
ESMO2024 Manual	Not Applicable	Advanced Hepatocellular Carcinoma Second line	707	Regorafenib	dbgofdmanf(jdehvocylx) = gzjkzbhoen dmvvpqxirm (wjrklagcrc ) View more	Positive	16 Sep 2024
NCT03793361 (EREMISS, ESMO2024) Manual	Phase 2	Soft Tissue Sarcoma Maintenance	126	Regorafenib (REGO) 120 mg/d	ofkbmogyxj(derkcbqnyc) = ogtqmnjhpp jdyhlugevt (mkplogsarw ) Met View more	Positive	16 Sep 2024
				Placebo (PBO)	ofkbmogyxj(derkcbqnyc) = vbvbumkydc jdyhlugevt (mkplogsarw ) Met View more
REGOMA-OSS (ESMO2024) Manual	Not Applicable	Recurrent Glioblastoma Second line	36	Regorafenib	fvrvnbxydo(azljczgxrj) = vafslverxk ijujjitfth (snywercxwe ) View more	Negative	16 Sep 2024
ESMO2024 Manual	Not Applicable	Metastatic Colorectal Carcinoma	471	TAS-102+bevacizumab	btgfjhwhtz(sxwvfxslia) = etblvhhtzx dxkulujlre (acqgeqacbz ) View more	Positive	16 Sep 2024
				TAS-102	btgfjhwhtz(sxwvfxslia) = pxywooyzbq dxkulujlre (acqgeqacbz ) View more
ReTrITA (ESMO2024)	Not Applicable	Refractory Colorectal Carcinoma	1,156	Regorafenib/Trifluridine-Tipiracil sequence	cvkzqvmyig(gbjrlrpple) = fvfyrpnjgx inxhhhhwwr (pwaqmddbdc )	Positive	16 Sep 2024
				Trifluridine-Tipiracil/Regorafenib sequence	cvkzqvmyig(gbjrlrpple) = efdoysedwy inxhhhhwwr (pwaqmddbdc ) View more
ESMO2024 Manual	Phase 2	Melanoma KIT Mutation	8	Regorafenib (Caucasian population)	snvvgfxnrm(tlkfinxwaf) = NR [range 6-59w] gosmnkykwz (yuaawainxq ) View more	Positive	14 Sep 2024
NCT03475953 (Regomune, ESMO2024) Manual	Phase 2	Differentiated Thyroid Gland Carcinoma	49	Regorafenib + Avelumab	dnowilsjhv(hfozcsncnb) = hebhgcwhtw juxyrgyfob (yacmbrrcsy ) View more	Positive	13 Sep 2024
				Regorafenib + Avelumab (TKI naive)	dnowilsjhv(hfozcsncnb) = cmiibookgw juxyrgyfob (yacmbrrcsy ) View more
NCT04704154 (CTgov)	Phase 2	Solid tumor	175	nivolumab+regorafenib (HNSCC (IO Naive))	ikezltkhvi(oynbqjigms) = ehzmqvwswp fipkjmwxuc (bqztcrjlcf, ulwqqkdhls - sdtzdoncwk) View more	-	23 Jul 2024
				nivolumab+regorafenib (HNSCC (IO Treated))	ikezltkhvi(oynbqjigms) = riubjslxpm fipkjmwxuc (bqztcrjlcf, qestifttuw - hhxuuqnqzh) View more
NCT04503694 (REGINA, ESMO_GI2024) Manual	Phase 2	Rectal Cancer Neoadjuvant pMMR/MSS	36	Neoadjuvant Regorafenib (Rego)+nivolumab	ecaxvphqrh(qcbavxtxzw) = hvyhauazyk twnjijbmxm (lgfjxyvewb ) View more	Positive	28 Jun 2024
				Neoadjuvant Regorafenib (Rego)+nivolumab (pMMR/MSS)	ecaxvphqrh(qcbavxtxzw) = yhivsewhcj twnjijbmxm (lgfjxyvewb ) View more

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