A Phase I Study of Zanzalintinib With Pembrolizumab and Cetuximab in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck

This Phase I clinical trial evaluates the safety, tolerability, and optimal dosing of Zanzalintinib in combination with Pembrolizumab and Cetuximab in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M HNSCC). The study aims to establish the maximally tolerated dose (MTD) and recommended Phase II dose (RP2D) while also exploring efficacy outcomes, including progression-free survival (PFS) and overall survival (OS).

Start Date05 Jun 2025

Sponsor / Collaborator

The University of Chicago

[+1]

NCT06943820

/ Not yet recruitingPhase 1/2

A Phase Ib/II Study of Anti-PD-1/LAG-3 Bispecific Antibody AK129 Combinations in Advanced Solid Tumors

This is an open, multicenter phase Ib/II clinical study. The goal of this study is to confirm the Phase II recommended dose (RP2D) of AK129 combinations for advanced solid tumors and evaluate the safety and efficacy of AK129 combinations for non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), colorectal adenocarcinoma (CRC), and other advanced solid tumors.

Start Date01 May 2025

Sponsor / Collaborator

Akeso Biopharma Co., Ltd.

NCT06935188

/ RecruitingPhase 2IIT

Dalpicilib Plus Cetuximab Compared With Cetuximab Alone in Patients With HPV-negative, Anti-PD-1-resistant Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: An Open Label, Randomized Controlled, Phase II Trial

This study is a single center, randomized controlled, prospective phase II clinical trial to evaluate the efficacy and safety of cetuximab combined with dalpicilib compared to cetuximab monotherapy in patients with HPV-negative, anti-PD-1-resistant recurrent or metastatic head and neck squamous cell carcinoma. The participants would receive cetuximab combined with dalpicilib or cetuximab monotherapy until termination criteria are met.

Start Date18 Apr 2025

Sponsor / Collaborator

The Ninth People's Hospital of Shanghai Jiaotong University Medical College

100 Clinical Results associated with Cetuximab

100 Translational Medicine associated with Cetuximab

100 Patents (Medical) associated with Cetuximab

8,331

Literatures (Medical) associated with Cetuximab

01 Dec 2025·Journal of Gastrointestinal Cancer

Efficacy and Safety of Anti-EGFR Therapy Rechallenge in Metastatic Colorectal Cancer: A Systematic Review and Meta-Analysis

Review

Author: de Oliveira Rodrigues, Anna Luíza Soares ; Limachi-Choque, Jhonny ; de Moraes, Francisco Cezar Aquino ; Burbano, Rommel Mario Rodríguez ; Priantti, Jonathan N

BACKGROUNDColorectal cancer (CRC) represents the second leading cause of cancer-related mortality worldwide, with a significant portion of patients presenting with metastatic disease at diagnosis. Resistance to initial anti-EGFR therapy, a key treatment for RAS wild-type metastatic CRC, remains a major challenge. This study aimed to assess the efficacy and safety of rechallenge with anti-EGFR therapy in patients with metastatic CRC who have progressed after prior treatments.METHODSA systematic search was conducted across PubMed, Web of Science, Cochrane, and Scopus. Studies were included if they were randomized controlled trials (RCTs) or observational studies involving patients with EGFR-mutated metastatic CRC who received anti-EGFR therapy as a rechallenge. Endpoints included objective response rate (ORR), disease control rate (DCR), and the incidence of adverse events. Statistical analyses were performed using the DerSimonian/Laird random effect model, with heterogeneity assessed via I² statistics. R, version 4.2.3, was used for statistical analyses.RESULTSFourteen studies were included with 520 patients; 50.3% were male, and the median age was 63 years old. The median progression-free survival (mPFS) ranged between 2.4 and 4.9 months, while the median overall survival (mOS) ranged from 5 to 17.8 months. Our pooled analysis demonstrated an objective response rate (ORR) of 17.70% (95% CI, 8.58-26.82%) and a disease control rate (DCR) of 61.72% (95% CI, 53.32-70.11%), both with significant heterogeneity (I², 84% and 80%, respectively; p < 0.01). In the subgroup analysis, cetuximab showed an ORR of 18.31% (95% CI, 4.67-31.94%), and panitumumab an ORR of 10.9% (95% CI, 0.00-26.82%), while the combination of both resulted in an ORR of 29.24% (95% CI, 0.00-65.84%). For DCR, cetuximab resulted in 62.1% (95% CI, 49.32-74.87%), panitumumab in 63.05% (95% CI, 52.13-73.97%), and the combination in 60.34% (95% CI, 31.92-88.77%), all with significant heterogeneity. Adverse events included anemia (15.39%), diarrhea (4.20%), hypomagnesemia (6.40%), neutropenia (22.57%), and skin rash (13.22%).CONCLUSIONSRechallenge with anti-EGFR therapy in metastatic CRC patients shows moderate efficacy with manageable safety profiles. These findings highlight the need for careful patient selection and monitoring to optimize outcomes. Further studies are warranted to refine strategies for maximizing the therapeutic benefits of anti-EGFR rechallenge.

01 Dec 2025·Journal of Gastrointestinal Cancer

Anti-EGFR Rechallenge in Metastatic Colorectal Cancer and the Role of ctDNA: A Systematic Review and Meta-analysis

Review

Author: Saldanha, Erick Figueiredo ; da Silva, Marcos Vinícius Martins Grangeiro ; Peixoto, Renata D 'Alpino ; Noronha, Mariana Macambira ; da Silva, Luís Felipe Leite ; da Conceição, Lucas Diniz

BACKGROUNDMetastatic colorectal cancer (mCRC) remains a significant clinical challenge. While anti-EGFR inhibitors have improved survival rates, their long-term efficacy is limited by disease progression, which is often associated with the development of acquired resistance mutations. However, some patients may regain sensitivity to anti-EGFR agents after alternative therapies, suggesting a potential benefit for rechallenge strategies. Our study aims to conduct a systematic review and meta-analysis to comprehensively evaluate the efficacy and safety of EGFR rechallenge in patients with mCRC.METHODSA systematic search of the MEDLINE, EMBASE, and Cochrane databases was conducted between October 28 and December 24, 2023, to identify clinical trials investigating treatment regimens incorporating panitumumab or cetuximab as a rechallenge strategy. Pooled proportions or hazard ratios (HR) were calculated using a random effects model. Inter-study heterogeneity was assessed using the I².RESULTSAmong the 2105 articles identified through the search, 13 met the predetermined inclusion criteria. Of these, 12 were phase II studies, encompassing 92.3% of the patient population. Cetuximab was administered to 302 patients (75.1%), whereas panitumumab was utilized in 100 patients (24.9%).A pooled analysis of eight studies demonstrated an objective response rate of 20.50% (95% CI 7.94 to 33.07) and a disease control rate of 67.35% (95% CI 58.60 to 76.09). The median progression-free survival was estimated at 3.5 months (95% CI 2.68-6.69), with a median OS of 9.8 months (95% CI 6.71-12.89). Patients exhibiting RAS wild-type status in circulating tumor DNA (ctDNA) analysis derived enhanced benefits from anti-EGFR rechallenge (HR: 0.41; 95% CI 0.28-0.60, I² = 60%). Common grade 3 or higher treatment-related adverse events included neutropenia (22.8%) and rash (14.9%).CONCLUSIONThis meta-analysis underscores the efficacy and safety of anti-EGFR rechallenge as a promising therapeutic approach for a subset of patients afflicted with mCRC. The observed correlation between wild-type RAS status, as determined through ctDNA analysis, and improved OS signals the prospect of precision oncology in guiding treatment decisions.

01 Jul 2025·Critical Reviews in Oncology/Hematology

KRAS G12C inhibitors as monotherapy or in combination for metastatic colorectal cancer: A proportion and comparative meta-analysis of efficacy and toxicity from phase I-II-III trials

Review

Author: Erul, Enes ; Akkus, Erman ; Öksüz, Nejat Emre

BACKGROUND1-2% of metastatic colorectal cancers (mCRC) harbor an activating KRAS-G12C mutation. This study aims to pool the results of available clinical trials of KRAS-G12C inhibitors, comparing monotherapy and combinations.METHODSA systematic literature search was conducted in the MEDLINE database and ESMO/ASCO meeting abstracts. Phase I-II-III trials that investigated a KRAS-G12C inhibitor in patients with mCRC were included. The primary endpoints were objective response rate (ORR) and progression-free survival (PFS). Pooled proportions and comparative subgroup analyses for monotherapy and combinations were presented with the random effects model.RESULTS596 patients with previously treated mCRC in 14 study cohorts treated with one of sotorasib, adagrasib, divarasib, or olomorasib as monotherapy or in combination with cetuximab/panitumumab were included. Combination treatment revealed an ORR of 33.9% (95%CI: 20.7- 48.4) (I²: 87.1), which is significantly higher than monotherapy [16.7%, (95%CI: 8.3-27.3) (I²: 73.2)] (p= 0.045). Median PFS was significantly longer with the combination [5.7 months (95%CI: 4.4-7.1) (I²: 80.8) vs. 4.2 months (95%CI: 3.6-4.7) (I²:0.0), p=0.027]. Grade 3-4 treatment-related adverse events were significantly more frequent with the combination [32.8% (95%CI: 26.4-39.6) (I²:42.5) vs.16.5% (95%CI: 4.9-33.1) (I²: 84.2), p=0.047]. Common adverse events specific to the combinations were skin toxicities, paronychia, and hypomagnesemia.CONCLUSIONThis analysis suggests that KRAS-G12C inhibitors in combination with anti-EGFR agents may provide a doubled ORR and 1.5-month PFS benefit compared to monotherapy in previously treated mCRC patients but with a doubled grade 3-4 TRAEs, including skin toxicities, paronychia, and hypomagnesemia. Treatment preferences should be individualized in these highly pretreated patients.

542

News (Medical) associated with Cetuximab

05 May 2025

·ir.nanobiotix.com

Nanobiotix Announces Full Results From Completed Phase 1 Study Evaluating JNJ-1900 (NBTXR3) in Pancreatic Cancer

Results demonstrated favorable safety, injection feasibility, and encouraging oncologic outcomes in patients (n=22) with locally advanced or borderline resectable pancreatic cancer Median Overall Survival of 23 months from date of diagnosis [95% CI; 17 months – not reached] Median Local Progression-Free Survival of 13.3 months from completion of radiation Notable findings observed in exploratory biomarker analyses include: An association between increased circulating tumor mutational burden (cTMB) and LPFS and OS CA19-9 normalization in 59% of patients in the study, and an association between CA19-9 normalization and OS First patient injected in a new cohort that adds standard-of-care concurrent chemotherapy (capecitabine or 5-FU) to radiotherapy-activated JNJ-1900 (NBTXR3) and recruitment is ongoing Investigators concluded that these results support further evaluation in a randomized study An association between increased circulating tumor mutational burden (cTMB) and LPFS and OS CA19-9 normalization in 59% of patients in the study, and an association between CA19-9 normalization and OS Data presented at the 2025 Annual Meeting of the European Society of Radiation Oncology PARIS and CAMBRIDGE, Mass., May 05, 2025 (GLOBE NEWSWIRE) -- NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-stage clinical biotechnology company pioneering nanotherapeutic approaches to improve treatment outcomes for patients with cancer, today announced the presentation of full results from the completed dose escalation and dose expansion phases of a Phase 1 study evaluating JNJ-1900 (NBTXR3) in patients with locally advanced or borderline resectable pancreatic cancer. The study, conducted by The University of Texas MD Anderson Cancer Center (“MD Anderson”), was presented by principal investigator Dr. Eugene Koay at the 2025 Annual Meeting of the European Society for Radiotherapy and Oncology (ESTRO 2025). Pancreatic ductal adenocarcinoma (PDAC) remains one of the most lethal malignancies, driven by aggressive tumor biology and limited responsiveness to standard therapies. For patients with locally advanced (“LAPC”) or borderline resectable (“BRPC”) disease, the current standard-of-care (“SOC”)—induction chemotherapy followed by chemoradiation—rarely delivers curative outcomes, underscoring the need for novel treatment approaches. “Patients with locally advanced or borderline resectable pancreatic cancer face a particularly urgent unmet need for therapeutic innovation that can provide a meaningful survival benefit with an acceptable safety profile,” said Eugene Koay, MD, PhD, Associate Professor of Radiation Oncology at MD Anderson. “We are encouraged by the results from the completed cohorts and look forward to the continued evaluation of JNJ-1900 (NBTXR3) in combination with standard-of-care chemoradiation after induction chemotherapy.” PRESENTATION #E25-2265: NANORAY Pancreas: A Phase 1 Study of NBTXR3 (JNJ-1900) Activated by Radiotherapy for Locally Advanced or Borderline Resectable Pancreatic Cancer (LAPC or BRPC)Koay EJ, Liu S, Guerrero P, Stokes E, Katz MHG, Ikoma N, Snyder RA, Tzeng CD, Overman MJ, Pant S, Wolff RA, Javle M, Holliday EB, Ludmir EB, Das P, Noticewala S, Koong AC, Tamm EP, Bhutani M This MD Anderson-sponsored Phase 1 study evaluated the potential of radiotherapy(“RT”)-activated JNJ-1900 (NBTXR3) activated by radiation therapy (45 Gy in 15 fractions) to overcome inherent radioresistance in patients with LAPC or BRPC. The majority of patients in the study (20/22) were diagnosed with locally advanced, unresectable disease (LAPC). For clarity, patients with LAPC or BRPC are traditionally treated with induction chemotherapy followed by concurrent chemoradiation. The treatment regimen in the completed dose escalation and dose expansion parts of this Phase 1 study replaced concurrent chemoradiation with RT-activated JNJ-1900 (NBTXR3) after induction chemotherapy. Key Results: Favorable safety profile and injection feasibility were observed (n=22) Median overall survival (“mOS”): 23 months from diagnosis [95% CI; 17 months – not reached] For context, an MD Anderson historical review of 144 patients with LAPC treated at the same center showed a mOS of 19.2 months. Patients in the historical review received induction chemotherapy followed by RT with or without concurrent or maintenance chemotherapy (80% received RT with concurrent chemotherapy) Median local progression-free survival (“mLPFS”): 13.3 months from completion of radiation Two LAPC patients achieved R0 surgical resection For context, an MD Anderson historical review of 144 patients with LAPC treated at the same center showed a mOS of 19.2 months. Patients in the historical review received induction chemotherapy followed by RT with or without concurrent or maintenance chemotherapy (80% received RT with concurrent chemotherapy) Exploratory Biomarker Analyses: Of the 20 patients for whom circulating Tumor Mutational Burden (cTMB) data was available, a notable proportion (40%; 8/20) exhibited increased cTMB, and investigators observed an association between increased cTMB and improved LPFS and OS Normalization of CA19-9, a surrogate for overall survival benefit, was observed in 59% of patients (11/22) and was associated with longer survival in the study. For context, an MD Anderson historical review of 243 patients with LAPC treated at the same center showed normalization of CA19-9 in approximately 17% of patients treated with the standard of care who had elevated CA19-9 levels at diagnosis For context, an MD Anderson historical review of 243 patients with LAPC treated at the same center showed normalization of CA19-9 in approximately 17% of patients treated with the standard of care who had elevated CA19-9 levels at diagnosis Based on the safety and preliminary efficacy findings, investigators concluded that further evaluation of JNJ-1900 (NBTXR3) is warranted in a randomized study. “Our collaboration with MD Anderson has always been driven by a shared commitment to exploring bold new approaches for patients with high unmet need,” said Louis Kayitalire, MD, Chief Medical Officer at Nanobiotix. “Given the extremely poor survival rates in LAPC and BRPC, the results from this Phase 1 study give us confidence in the potential of JNJ-1900 (NBTXR3) to serve as a meaningful addition to the treatment landscape. We are particularly excited about the potential to further enhance outcomes through combination of JNJ-1900 (NBTXR3) with SOC chemoradiation in the study’s new active cohort, and we look forward to advancing this program in pancreatic cancer.” MD Anderson received FDA clearance to expand the study to include a new cohort that combines of JNJ-1900 (NBTXR3) with SOC concurrent chemoradiation after induction chemotherapy. The first patient in the new cohort has been injected, and recruitment is ongoing. Nanobiotix Conference Call Nanobiotix will host a conference call and webcast featuring Nanobiotix Chief Executive Officer and Chairman of the Executive Board, Laurent Levy, to discuss the data on Monday May 5th, 2025, at 8:00 AM EDT / 2:00 PM CEST. Details for the call are as follows: Webcast link: click here Audio-only dial-in link: click here Participants can use the audio-only link above to register and obtain dial-in instructions to listen to the presentation via phone and ask questions during the Q&A session, or participants can use the webcast link to register and listen and watch the slide presentation online; the replay version will be available under the same webcast link shortly after the presentation and will be archived on the Company’s website at www.nanobiotix.com. It is recommended to join 10 minutes prior to the event start. Participants are invited to email their questions in advance to investors@nanobiotix.com. About JNJ-1900 (NBTXR3) JNJ-1900 (NBTXR3) is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. Its proof-of-concept was achieved in soft tissue sarcomas through a successful randomized Phase 2/3 study in 2018. The product candidate’s physical mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that JNJ-1900 (NBTXR3) could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors. Radiotherapy-activated JNJ-1900 (NBTXR3) is being evaluated across multiple solid tumor indications as a single agent or combination therapy. The program is led by NANORAY-312—a global, randomized Phase 3 study in locally advanced head and neck squamous cell cancers. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of JNJ-1900 (NBTXR3) activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the Phase 3 study. Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several Phase 1 and Phase 2 studies evaluating JNJ-1900 (NBTXR3) across tumor types and therapeutic combinations. In 2023, Nanobiotix announced a license agreement for the global co-development and commercialization of JNJ-1900 (NBTXR3) with Janssen Pharmaceutica NV, a Johnson & Johnson company. About NANOBIOTIX Nanobiotix is a late-stage clinical biotechnology company pioneering disruptive, physics-based therapeutic approaches to revolutionize treatment outcomes for millions of patients; supported by people committed to making a difference for humanity. The Company’s philosophy is rooted in the concept of pushing past the boundaries of what is known to expand possibilities for human life. Incorporated in 2003, Nanobiotix is headquartered in Paris, France and is listed on Euronext Paris since 2012 and on the Nasdaq Global Select Market in New York City since December 2020. The Company has subsidiaries in Cambridge, Massachusetts (United States) amongst other locations. Nanobiotix is the owner of more than 25 umbrella patents associated with three (3) nanotechnology platforms with applications in 1) oncology; 2) bioavailability and biodistribution; and 3) disorders of the central nervous system. For more information about Nanobiotix, visit us at www.nanobiotix.com or follow us on LinkedIn and Twitter Disclaimer This press release contains “forward-looking” statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the use of proceed therefrom, and the period of time through which the Company’s anticipates its financial resources will be adequate to support operations. Words such as “expects”, “intends”, “can”, “could”, “may”, “might”, “plan”, “potential”, “should” and “will” or the negative of these and similar expressions are intended to identify forward-looking statements. These forward-looking statements which are based on the Company’ management’s current expectations and assumptions and on information currently available to management. These forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from those implied by the forward-looking statements, including risks related to Nanobiotix’s business and financial performance, which include the risk that assumptions underlying the Company’s cash runway projections are not realized. Further information on the risk factors that may affect company business and financial performance is included in Nanobiotix’s Annual Report on Form 20-F filed with the SEC on April 02, 2025 under “Item 3.D. Risk Factors”, in Nanobiotix’s 2024 universal registration document filed with the AMF on April 02, 2025,, and subsequent filings Nanobiotix makes with the SEC from time to time which are available on the SEC’s website at www.sec.gov. The forward-looking statements included in this press release speak only as of the date of this press release, and except as required by law, Nanobiotix assumes no obligation to update these forward-looking statements publicly. Contacts Attachment 2025-05-05 -- NBTX -- Full Ph1 NBTXR3 Results in Pancreatic Cancer -- FINAL

Clinical ResultPhase 3Phase 1Fast TrackLicense out/in

29 Apr 2025

·investors.erasca.com

Erasca Presents New Preclinical Data Reinforcing Best-in-Class Potential of RAS-Targeting Franchise at the 2025 AACR Annual Meeting

ERAS-0015 and ERAS-4001 showed robust anti-tumor activity as monotherapy and combination therapy First-in-class examples of direct SHOC2 binders and modulators of SMP complex assembly identified with potential to block oncogenic RAS/MAPK pathway signaling SAN DIEGO, April 29, 2025 (GLOBE NEWSWIRE) -- Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, today presented new preclinical data reinforcing the best-in-class profiles of Erasca’s RAS-targeting franchise at the American Association for Cancer Research (AACR) Annual Meeting in Chicago, Illinois. The Company also presented potential first-in-class examples of direct SHOC2 binders and modulators of SMP complex assembly, representing a new approach to block oncogenic RAS/MAPK pathway signaling. The posters are available online at Erasca.com/science/#presentations. “We were pleased to present new preclinical data at this year’s AACR meeting further solidifying our understanding of the properties that support the best-in-class potential of our pan-RAS molecular glue ERAS-0015 and the best-in-class/first-in-class potential of our pan-KRAS inhibitor ERAS-4001. We also showcased our research capabilities with, to our knowledge, the first identification of direct SHOC2 binders targeting the RAS/MAPK pathway in collaboration with our scientific advisory board member Pablo Rodriguez-Viciana,” said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. “Importantly, these data reinforce the favorable pharmacokinetic properties that allow for robust anti-tumor activity at significantly lower doses of ERAS-0015 versus the leading pan-RAS molecular glue in development, as well as the potential expanded therapeutic index of ERAS-4001 through selective targeting of key KRAS mutations. We are excited to achieve our goal of advancing development of both RAS-targeting compounds in the clinic this year.” Poster Presentation Highlights Abstract 390 – ERAS-0015 is a pan-RAS molecular glue with best-in-class potential in RAS mutant solid tumors ERAS-0015 demonstrated favorable pharmacokinetic properties including longer residence time and greater tissue exposure that led to robust anti-tumor activity alone and in combination at doses lower than the leading pan-RAS molecular glue in development. ERAS-0015 is a pan-RAS molecular glue designed to shut down pathogenic signaling mediated by mutant and wildtype RAS by targeting RAS in the GTP-bound state. 8-21-fold greater cyclophilin A (CypA) binding for ERAS-0015 vs. pan-RAS molecular glue comparator RMC-6236 ERAS-0015 dose-dependently formed a ternary complex with active state RAS and CypA, which blocks formation of additional downstream effector complexes Potent inhibition of proliferation with ERAS-0015 across a panel of cell lines spanning diverse tumor tissues and RAS mutations Preferential drug distribution into tumor tissues Promising monotherapy and combination activity across multiple RAS mutant models Abstract 4367 – ERAS-4001 is a pan-KRAS inhibitor with robust anti-tumor activity in KRAS altered solid tumors ERAS-4001 potentially has an expanded therapeutic index relative to pan-RAS inhibitors by selectively targeting both mutant and wildtype KRAS, leading to significant tumor growth inhibition alone and in combination. Selectively targeting both wildtype (WT) and oncogenic KRAS may address resistance mechanisms to mutant-selective KRAS inhibitors that are driven by WT KRAS activity. A potential first-in-class pan-KRAS inhibitor, ERAS-4001 is a novel, highly potent pan-KRAS inhibitor that blocks mutant and WT KRAS, potentially offering improved tolerability relative to pan-RAS inhibitors by sparing NRAS and HRAS. ERAS-4001 selectively inhibited KRAS mutant enzymes and WT KRAS over WT HRAS and NRAS ERAS-4001 inhibited 3D cell viability and proliferation in 13 G12X mutant and one wildtype KRAS amplified cell lines across indications with single digit nanomolar IC50s Dose-dependent tumor growth inhibition and significant antitumor efficacy with ERAS-4001 monotherapy in KRAS mutant xenograft models Robust tumor growth inhibition with ERAS-4001 plus anti-PD-1 or cetuximab in KRAS mutant models Promising antitumor monotherapy and combination activity across multiple KRAS mutant models Abstract 3152 – Identification and characterization of inhibitors of SHOC2-MRAS-PP1C complex assembly Identified inhibitors of SMP complex assembly via SHOC2 engagement, representing a potential new approach to attenuate RAS/MAPK pathway signaling. Genetic ablation or protein degradation of SHOC2 can sensitize RAS-driven cells to RAS/MAPK pathway inhibitors and prevent adaptive resistance. Identified two lead series that bind selectively to SHOC2 with low nanomolar affinity, interfere with SMP complex assembly, and inhibit the SMP complex’s phosphatase activity To our knowledge, these compounds represent the first examples of direct modulators of the SMP complex Further optimization of SHOC2 binders for protein-protein inhibitors (PPIs) and degrader modalities is ongoing About Erasca At Erasca, our name is our mission: To erase cancer. We are a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers. Our company was co-founded by leading pioneers in precision oncology and RAS targeting to create novel therapies and combination regimens designed to comprehensively shut down the RAS/MAPK pathway for the treatment of patients with cancer. We have assembled one of the deepest RAS/MAPK pathway-focused pipelines in the industry. We believe our team’s capabilities and experience, further guided by our scientific advisory board which includes the world’s leading experts in the RAS/MAPK pathway, uniquely position us to achieve our bold mission of erasing cancer. Cautionary Note Regarding Forward-Looking Statements Erasca cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to: our expectations regarding the potential therapeutic benefits of our product candidates and early-stage development projects, including ERAS-0015, ERAS-4001, and our SHOC2 binding project; and our ability to achieve our goal of initiating the clinical development of ERAS-0015 and ERAS-4001 this year. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: our approach to the development of product candidates based on our singular focus on shutting down the RAS/MAPK pathway, a novel and unproven approach; results from preclinical studies not necessarily being predictive of future results; our assumptions around which programs may have a higher probability of success may not be accurate, and we may expend our limited resources to pursue a particular product candidate and/or indication and fail to capitalize on product candidates or indications with greater development or commercial potential; potential delays in the commencement, enrollment, and completion of clinical trials and preclinical studies; our dependence on third parties in connection with manufacturing, research, and preclinical and clinical testing; unexpected adverse side effects or inadequate efficacy of our product candidates that may limit their development, regulatory approval, and/or commercialization, or may result in recalls or product liability claims; unfavorable results from preclinical studies or clinical trials; the inability to realize any benefits from our current licenses, acquisitions, and collaborations, and any future licenses, acquisitions, or collaborations, and our ability to fulfill our obligations under such arrangements; regulatory developments in the United States and foreign countries; our ability to fund our operating plans with our current cash, cash equivalents, and marketable securities; and other risks described in our prior filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K for the year ended December 31, 2024, and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contact: Joyce Allaire LifeSci Advisors, LLC jallaire@lifesciadvisors.com Source: Erasca, Inc. Source: Erasca, Inc.

AACR

28 Apr 2025

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AVEO Oncology, an LG Chem company, Announces Three Poster Presentations at ASCO 2025 Annual Meeting

BOSTON, April 28, 2025 /PRNewswire/ -- AVEO Oncology, an LG Chem company ("AVEO"), a biopharmaceutical company committed to providing differentiated solutions to improve cancer patients lives, announced today that three abstracts were accepted for presentation at the upcoming American Society of Clinical Oncology (ASCO) 2025 annual meeting this May 30-June 3, 2025, in Chicago, IL. Presentation Details Title: Efficacy of second line (2L) treatment with tivozanib (Tivo) as monotherapy or with nivolumab (Nivo) in patients (pts) with metastatic renal cell carcinoma (mRCC) previously treated with an immune checkpoint inhibitor (ICI) combination of ipilimumab (Ipi)/Nivo or vascular endothelial growth factor receptor-tyrosine kinase inhibitor (VEGFR-TKI)/ICI in the Phase 3 TiNivo-2 study First Author: Alexander Chehrazi-Raffle, MD, City of Hope Cancer Center Abstract Number: 4540 Poster Session: Genitourinary Cancer—Kidney and Bladder Poster Board: 340 Date and Time: Monday, June 2, 2025, 9:00am – 12:00 PM CDT Title: FIERCE-HN: A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of ficlatuzumab (HGF/cMET Mab) in combination with cetuximab in participants with recurrent or metastatic (R/M) HPV negative head and neck squamous cell carcinoma (HNSCC) First Author: Julie E. Bauman, MD, MPH, George Washington University Cancer Center Abstract Number: TPS6115 Poster Session: Head and Neck Cancer Poster Board: 520a Date and Time: Monday, June 2, 2025, 9:00 AM – 12:00 PM CDT Title: A phase1b dose escalation study of AV-380 (anti-GDF15 monoclonal antibody) in combination with standard-of-care therapy in cancer patients with cachexia First Author: Eric Roeland, MD, FAAHPM, Oregon Health & Science University Abstract Number: TPS12142 Poster Session: Symptom Science and Palliative Care Poster Board: 159a Date and Time: Monday, June 2, 2025, 1:30-4:30 PM CDT About AVEO Pharmaceuticals, Inc. AVEO is an oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. AVEO currently markets FOTIVDA® (tivozanib) in the U.S. for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. AVEO and its strategic partners continue to develop FOTIVDA in other novel targeted combinations in RCC. The company also has investigational programs in other areas of high unmet need, including ficlatuzumab in HPV-negative refractory head and neck squamous cell carcinoma and AV-380 in cancer cachexia. AVEO became a wholly owned subsidiary of LG Chem Life Sciences USA, Inc. on January 19, 2023. AVEO continues to operate under the AVEO Oncology, an LG Chem company, name. About LG Chem, Ltd. and LG Chem Life Sciences LG Chem, Ltd. (LG Chem) is a leading global chemical company with a diversified business portfolio in the key areas of petrochemicals, advanced materials, and life sciences. The company manufactures a wide range of products from high-value added petrochemicals to renewable plastics, specializing in cutting- edge electronic and battery materials, as well as drugs and vaccines to deliver differentiated solutions for its customers. LG Chem Life Sciences develops, manufactures, and globally commercializes pharmaceutical products, with a focus on Oncology, Immunology, and Metabolic diseases. Our mission is to transform people's lives through inspiring science and leading innovation. For more information, please visit . Contacts Media: John F. Kouten JFK Communications, Inc. [email protected] (908) 227-4714 SOURCE AVEO, an LG Chem company WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ImmunotherapyDrug ApprovalASCOPhase 3

100 Deals associated with Cetuximab

External Link

KEGG	Wiki	ATC	Drug Bank
D03455	Cetuximab	L01XC06	DB00002

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
RAS Wild Type Colorectal Cancer	Australia	Merck Healthcare Pty Ltd.	25 Sep 2007
Head and Neck Neoplasms	United States	Eli Lilly & Co.	01 Mar 2006
Metastatic Colorectal Carcinoma	Norway	Merck Europe BV	29 Jun 2004
Metastatic Colorectal Carcinoma	European Union	Merck Europe BV	29 Jun 2004
Metastatic Colorectal Carcinoma	Liechtenstein	Merck Europe BV	29 Jun 2004
Metastatic Colorectal Carcinoma	Iceland	Merck Europe BV	29 Jun 2004
Squamous Cell Carcinoma of Head and Neck	Iceland	Merck Europe BV	29 Jun 2004
Squamous Cell Carcinoma of Head and Neck	Norway	Merck Europe BV	29 Jun 2004
Squamous Cell Carcinoma of Head and Neck	European Union	Merck Europe BV	29 Jun 2004
Squamous Cell Carcinoma of Head and Neck	Liechtenstein	Merck Europe BV	29 Jun 2004
Colorectal Cancer	Switzerland	Merck & Co., Inc.	01 Dec 2003

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
EGFR positive Neoplasms	Phase 2	Netherlands	Bristol Myers Squibb Co.	01 Apr 2003
EGFR positive Neoplasms	Phase 2	Australia	Eli Lilly & Co.	01 Apr 2003
EGFR positive Neoplasms	Phase 2	United Kingdom	Bristol Myers Squibb Co.	01 Apr 2003
EGFR positive Neoplasms	Phase 2	Sweden	Eli Lilly & Co.	01 Apr 2003
EGFR positive Neoplasms	Phase 2	Switzerland	Eli Lilly & Co.	01 Apr 2003
Metastatic Colorectal Carcinoma	Phase 2	United States	Eli Lilly & Co.	01 Mar 2003
Metastatic Colorectal Carcinoma	Phase 2	United States	Bristol Myers Squibb Co.	01 Mar 2003
Metastatic Colorectal Carcinoma	Phase 2	United States	Eli Lilly & Co.	01 Mar 2003
Metastatic Colorectal Carcinoma	Phase 2	United States	Bristol Myers Squibb Co.	01 Mar 2003

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04495621 (C-PRECISE-01, CTgov)	Phase 1/2	Metastatic Colorectal Carcinoma	29	cetuximab+MEN1611 (Phase 1b (Dose Confirmation))	(pcapuepbza) = ipfdadoofj ozkfqaumhf (fawjqupycp, nehphxapcv - dqrvyugkff) View more	-	01 May 2025
				cetuximab+MEN1611 (Phase 2 (Cohort Expansion))	(iykavgmlkk) = wtgnwrcxfa jrcmwomjuo (rjtkbthplf, tyvecmakri - zjlkjemmwc) View more
NCT03785249 (KRYSTAL-1, ESMO_ELCC2025)	Phase 1	Advanced Lung Non-Small Cell Carcinoma KRASG12C-mutated	31	Adagrasib 400 mg BID + Cetuximab 500 mg/m2 Q2W	(asfpyxzzrs) = dcfjkgaqxk zycfxfaesm (gwnschytow, 22.7 - 59.4) View more	Negative	26 Mar 2025
NCT00545545 (CTgov)	Phase 1/2	Colorectal cancer recurrent \| Colorectal Cancer	32	PGG+Cetuximab+Irinotecan (Arm 1, Imprime PGG Injection 2 mg/kg+ Cetuximab + Irinotecan)	mwslsfycjh(scifiednof) = yyewbpzcur ixwjmmtsqe (ifvnkjtady, qzhcwxvlop - hrgwiaxfip) View more	-	19 Mar 2025
				PGG+Cetuximab+Irinotecan (Arm 1, Imprime PGG Injection 4 mg/kg+ Cetuximab + Irinotecan)	mwslsfycjh(scifiednof) = gdsstmgufl ixwjmmtsqe (ifvnkjtady, ugusotkoiv - tlervxouur) View more
CTR20202451 (KL140-Ⅲ-02-CTP, NEWS) Manual	Phase 3	RAS Wild Type Colorectal Cancer First line	688	西妥昔单抗N01 + 化疗	(hylygspkwo) = yoydpzvnuq saqfizddib (qlzzsbnzla ) View more	Similar	07 Feb 2025
				西妥昔单抗注射液（爱必妥®）+ 化疗	(hylygspkwo) = lwzrlhuder saqfizddib (qlzzsbnzla ) View more
NCT04017650 (ASCO_GI2025) Manual	Phase 1/2	BRAF V600E mutant Colorectal Cancer \| Metastatic Microsatellite Stable Colorectal Carcinoma \|	12	Encorafenib + cetuximab + nivolumab	(cvwoftkzai) = ftahyfcpbq rrzbcizyhn (brznozhsuo, 1.7 - 5.7) View more	Negative	23 Jan 2025
NCT03785249 (KRYSTAL-1, ASCO_GI2025) Manual	Phase 1/2	KRAS G12C mutant Colorectal Cancer Second line	94	Adagrasib + Cetuximab	(wokvpknmhy) = tuuxxczela qnupzimhbl (tudrrzwowq, 32 - 53) View more	Positive	23 Jan 2025
NCT05009329 \| NCT05194995 (ASCO_GI2025) Manual	Phase 1/2	KRAS G12C mutant Colorectal Cancer	44	Glecirasib 800mg QD	(kdhssqxrkw) = iuiwncmiju ewgrmxcgps (vnywqlavol ) View more	Positive	23 Jan 2025
				Glecirasib 800mg QD + Cetuximab	(kdhssqxrkw) = tnodbjywqw ewgrmxcgps (vnywqlavol ) View more
NCT04607421 (BREAKWATER, ASCO_GI2025 \| Pubmed \| FDA) Manual	Phase 3	BRAF V600E mutant Colorectal Cancer First line	479	Encorafenib + Cetuximab + FOLFOX	(eqpqgfkmyy) = kokmhrttbs zjykzmqdri (zcfndttjma, 51.6 - 69.5) View more	Positive	23 Jan 2025
				Standard of Care (chemo with or without bevacizumab)	(eqpqgfkmyy) = tlpzzzhyxb zjykzmqdri (zcfndttjma, 31.3 - 49.3) View more
NCT02515734 (JACCRO CC-13, ASCO_GI2025) Manual	Phase 2	RAS Wild Type Colorectal Cancer RAS wild-type	359	m-FOLFOXIRI plus cetuximab	(tqjrkxujwu) = zpdzhhkepr rwjsdmrkbb (plkqlzfduw ) View more	Positive	23 Jan 2025
				m-FOLFOXIRI plus bevacizumab	(tqjrkxujwu) = ugmfbnlbcg rwjsdmrkbb (plkqlzfduw ) View more
NCT03365882 (S1613, Pubmed) Manual	Phase 2	RAS/BRAF Wild Type HER2 Positive Colorectal Cancer Second line \| Third line	54	Trastuzumab plus Pertuzumab	(vkrfazxyiv) = yjpwmdgrce wpqulrjtlb (zlkmnzqorc, 1.9 - 7.6) View more	Positive	06 Jan 2025
				Cetuximab plus Irinotecan	(vkrfazxyiv) = zbjlysxcjx wpqulrjtlb (zlkmnzqorc, 1.6 - 6.7) View more

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