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Last update 06 Feb 2026

Atezolizumab

Last update 06 Feb 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Anti-PDL-1-Genentech/Roche, Atezolizumab (Genetical Recombination), Atezolizumab (genetical recombination) (JAN)

+ [11]

Target

PDL1

Action

inhibitors

Mechanism

PDL1 inhibitors(Programmed death-ligand 1 inhibitors)

Therapeutic Areas

NeoplasmsImmune System DiseasesDigestive System Disorders+ [10]

Active Indication

Extranodal NK-T-Cell LymphomaAdvanced Lung Non-Small Cell CarcinomaBreast Cancer+ [155]

Inactive Indication

Adenocarcinoma of large intestineAdvanced Bile Duct CarcinomaAdvanced biliary tract cancer+ [91]

Originator Organization

Genentech, Inc.

Universitair Medisch Centrum Groningen

Active Organization

Hoffmann-La Roche, Inc.Roche Registration GmbH

Genentech, Inc.

+ [22]

Inactive Organization

Sanofi

Roche Farma SA

Kymab Ltd.

+ [10]

License Organization

NeoImmuneTech, Inc.

Harpoon Therapeutics, Inc.Novocure, Inc.

+ [26]

Drug Highest PhaseApproved

First Approval Date

United States (18 May 2016),

Transitional Cell Carcinoma

RegulationFast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (Japan), Orphan Drug (Australia), Priority Review (Australia), Conditional marketing approval (China), Priority Review (China), Breakthrough Therapy (United States)

Structure/Sequence

Sequence Code 122091L

Source: *****

Sequence Code 4720027H

Source: *****

875

Clinical Trials associated with Atezolizumab

NCT07388524

/ Not yet recruitingPhase 3IIT

Evaluating Adjuvant Atezolizumab or Atezolizumab and Hyaluronidase-TQJS to Prevent Recurrence in Stage I Non-Small Cell Lung Cancer (NSCLC): A Randomized Phase III Trial (AASI-NSCLC)

This phase III trial compares the effect of atezolizumab (or atezolizumab and recombinant human hyaluronidase) to standard observation for preventing cancer return after surgery (recurrence) in patients who have undergone a complete surgical removal (resection) of stage I non-small cell lung cancer (NSCLC). Patients who have undergone resection for lung cancer are typically followed by observation or active surveillance, which involves closely watching a patient's condition but not giving treatment unless there are changes in test results. During active surveillance, patients are given certain exams and tests done on a regular schedule. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Atezolizumab and recombinant human hyaluronidase is a formulation of atezolizumab combined with an enzyme called hyaluronidase, which helps increase tissue absorption of the drug. Giving atezolizumab or atezolizumab and recombinant human hyaluronidase after resection may be effective for preventing NSCLC recurrence, and may be a better approach to treating patients with stage I NSCLC than the usual observation approach.

Start Date09 Apr 2026

Sponsor / Collaborator

National Cancer Institute

NCT07322341

/ Not yet recruitingPhase 2IIT

A Phase 2 Trial of SX-682 and Atezolizumab in Patients With Advanced NSCLC Who Progressed on Prior Chemotherapy and Immune Checkpoint Inhibitor (ICI) Therapy

This phase II trial tests how well SX-682 and atezolizumab works for the treatment of non-small cell lung cancer (NSCLC) 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), and has come back after a period of improvement (recurrent). SX-682 blocks proteins that may be able to stimulate the immune system to kill and eliminate tumor cells. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving SX-682 and atezolizumab may be effective for the treatment of advanced or metastatic, recurrent NSCLC.

Start Date01 Mar 2026

Sponsor / Collaborator

University of Washington

[+3]

NCT07339059

/ RecruitingPhase 2IIT

Phase II Study of Sacituzumab Govitecan With Atezolizumab/Durvalumab as Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer

The goal of this clinical trial is to learn if the combination of sacituzumab govetican (SG) and atezolizumab/durvalumab is effective in controlling cancer tumor growth in adults with extensive stage small cell lung cancer. These drugs are FDA approved individually in different cancers. This combination is evaluated in breast cancer and showed promising combination.
The effectiveness of this treatment combination will be measured by changes in tumor size and appearance of new tumors.
Participants in the trial will:
* receive treatment SG and immunotherapy every 21 days for up to 2 years or until it is no longer works for the patient.
* CT scans at 6weeks for first 6 cycles and then every 9-12 weeks and MRI brain every 12 weeks.
* provide tissue (optional) and blood for additional testing (learn about the cancer).

Start Date01 Feb 2026

Sponsor / Collaborator

Henry Ford Health System

[+1]

100 Clinical Results associated with Atezolizumab

100 Translational Medicine associated with Atezolizumab

100 Patents (Medical) associated with Atezolizumab

4,158

Literatures (Medical) associated with Atezolizumab

01 Apr 2026·DEN open

A Case of Obstructive Jaundice due to Bile Duct Tumor Thrombus of Hepatocellular Carcinoma Diagnosed by Peroral Cholangioscopy

Article

Author: Tokumaru, Tomoko ; Endo, Mizuki ; Kinoshita, Keisuke ; Uchida, Takuro ; Murakami, Kazunari ; Okamoto, Kazuhisa ; Saito, Tomoko ; Iwao, Masao ; Kodama, Masaaki ; Arakawa, Mie

Abstract:

While hepatocellular carcinoma (HCC) often invades the portal or hepatic vein to form tumor thrombus, tumor thrombus in the bile duct is rare. In such cases, differentiation from intrahepatic cholangiocarcinoma is difficult, and the tumor often appears as a smooth, yellowish‐white, polypoid mass within the bile duct lumen. We report herein a case of obstructive jaundice due to bile duct tumor thrombus of HCC diagnosed by peroral cholangioscopy (POCS). A 64‐year‐old man presented with epigastralgia and jaundice. Contrast‐enhanced computed tomography revealed an irregular mass with hypoenhancement in liver segment S8, along with dilatation of the right intrahepatic bile duct due to the invading tumor. The hepatic mass was poorly visualized on ultrasound, making percutaneous liver tumor biopsy difficult. POCS was performed after endoscopic retrograde cholangiopancreatography for biopsy of the intrahepatic bile duct tumor thrombus. POCS clearly revealed a smooth, yellowish‐white, polypoid tumor in the right intrahepatic bile duct, and a biopsy of the tumor was performed under POCS. Based on the pathological findings, HCC was diagnosed, and chemotherapy with atezolizumab and bevacizumab was initiated.

01 Apr 2026·DEN open

A Rare Case of Immune‐related Adverse Events Localized to the Small Intestine

Article

Author: Morikawa, Ryo ; Taguchi, Towako ; Fukuda, Masayoshi ; Okamoto, Ryuichi ; Fujii, Toshimitsu ; Kanaya, Ryosuke ; Nemoto, Yasuhiro ; Yamamoto, Kurara ; Ohtsuka, Kazuo ; Shimizu, Hiromichi

ABSTRACT:

Enterocolitis is a common gastrointestinal manifestation of immune‐related adverse events (irAEs); however, only a few studies have reported on irAE enteritis with localized active inflammation in the small intestine. Here, we report the case of a 74‐year‐old man who developed diarrhea, abdominal pain, and oral intake difficulty and was subsequently hospitalized after receiving atezolizumab for pulmonary adenocarcinoma. Computed tomography and enterocolonoscopy revealed active inflammation in the small intestine but not in the colon, leading to the final diagnosis of irAE enteritis. After initiating prednisolone at a dose of 60 mg/day, his symptoms improved rapidly, and a follow‐up enterocolonoscopy revealed a marked reduction in inflammation. Being a relatively rare gastrointestinal toxicity, irAE enteritis often goes unrecognized due to diagnostic challenges, but can lead to serious AEs such as perforation. Therefore, even if colonoscopy findings are normal, a thorough examination of the small intestine is essential for patients who develop gastrointestinal symptoms while undergoing immune checkpoint inhibitor therapy. We herein report a rare case of irAE enteritis confirmed through endoscopic and pathological examination, which has not been previously reported.

01 Apr 2026·BREAST

Patient-reported outcomes from the randomized ALICE trial evaluating the addition of atezolizumab to anthracycline-based chemotherapy in metastatic triple-negative breast cancer

Article

Author: Kaasa, S ; Bjerre, C ; Jakobsen, E H ; Kyte, J A ; Falk, R S ; Gilje, B ; Svalheim, K G ; Naume, B ; Andresen, N K

BACKGROUND:

The ALICE trial demonstrated that adding atezolizumab to anthracycline-based immunomodulatory chemotherapy improved progression-free survival (PFS) in patients with metastatic triple-negative breast cancer (mTNBC), including those with PD-L1-negative tumors. Here, we report the patient-reported outcome measures (PROMs).

METHODS:

Patients were randomized to receive chemotherapy plus atezolizumab (atezo-chemo) or chemotherapy plus placebo (placebo-chemo). PROMs were collected at baseline and weeks 9, 17, 25, and 49 using the EORTC QLQ-C15-PAL, Chalder Fatigue Questionnaire (CFQ), and Numeric Rating Scale (NRS) for pain.

RESULTS:

PROMs were available from 64 of 68 patients. At week 9, mean changes from baseline favored the atezo-chemo arm across all QLQ-C15-PAL domains, CFQ scores, and NRS pain intensity. Time-to-deterioration analyses also favored atezo-chemo, with statistically significant hazard ratios for global quality of life (QoL; HR 0.24), emotional functioning (HR 0.30), and pain (HR 0.20). Pain-a pre-specified cardinal symptom-improved in the atezo-chemo group at all time points. At 12 months, PROMs indicated sustained tolerability. Better baseline PROM scores were associated with improved PFS and overall survival, especially among patients treated with atezolizumab. Patients with >median QoL score at baseline recorded improved PFS when treated with atezolizumab (HR 0.25), while patients with ≤median QoL score did not (HR 1.02).

CONCLUSIONS:

Adding atezolizumab to the study-chemotherapy in mTNBC improves both PFS and patient-reported quality of life, emotional well-being and symptom control. These findings support continued development of this combination regimen and suggest that baseline quality of life may serve as a useful predictor of immunotherapy benefit.

TRIAL REGISTRATION:

NCT03164993, May 24^th 2017; https://clinicaltrials.gov/ct2/show/record/NCT03164993.

1,562

News (Medical) associated with Atezolizumab

03 Feb 2026

·www.biospace.com

Replimune Reports Fiscal Third Quarter 2026 Financial Results and Provides Corporate Update

April 10, 2026 Target Action Date for RP1 in Advanced Melanoma WOBURN, Mass., Feb. 03, 2026 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced financial results for the fiscal third quarter ended December 31, 2025 and provided a business update. The Company's Biologics License Application (BLA) resubmission for RP1 (vusolimogene oderparepvec) in anti-PD-1 failed melanoma was accepted by the FDA in October 2025 with a Prescription Drug User Fee Act (PDUFA) target action date of April 10, 2026. Commercial readiness activities are well underway to support a potential launch, if approved. The Company has amended its existing loan agreement with Hercules Capital, Inc. The amendment included the draw down of $35 million upon closing and the potential to draw another $120 million at post approval milestones. The amendment also delays the repayment of debt from 2026 to 2027. The Company has extended its cash runway late into to the first quarter of 2027. "We have been engaged with the FDA in the review of the BLA resubmission for RP1,” said Sushil Patel, Ph.D., CEO of Replimune. "Advanced melanoma patients can progress quickly and are in urgent need of safe and effective treatment options. Our team remains ready to launch RP1 with commercial supply produced and the commercial organization prepared to engage with our target accounts rapidly, assuming FDA approval.” Program Highlights & Milestones RP1 (vusolimogene oderparepvec) IGNYTE-3 Confirmatory Study: The global Phase 3 trial will enroll approximately 400 patients and is assessing RP1 in combination with nivolumab versus physician's choice in patients with advanced melanoma who have progressed on anti-PD-1 and anti-CTLA-4 therapies or are ineligible for anti-CTLA-4 treatment. The primary endpoint of this trial is overall survival, and key secondary endpoints are progression free survival and overall response rate. Acral Melanoma: Recent data for RP1 plus nivolumab was recently presented at the ESMO Congress 2025. The analysis of acral melanoma data from the IGNYTE anti-PD-1 failed melanoma cohort showed treatment with RP1 combined with nivolumab resulted in an objective response rate (ORR) of 44% (8/18) with a median duration of response of 11.9 months. The safety pro favorable with generally transient grade 1 and 2 treatment related adverse events. Advanced Non-melanoma Skin Cancer (NMSC) Studies: Additionally, a poster from ESMO featuring data from the IGNYTE clinical trial showed that RP1 plus nivolumab provided responses across multiple advanced non-melanoma skin cancer (NMSC) tumor types, including anti–PD-1 naïve and failed disease, as well as both in locally advanced and metastatic disease. The ORR was 100.0%, 33.3%, 66.7%, and 56.3% in patients with anti–PD-1 naïve MCC, BCC, angiosarcoma, and CSCC, respectively. The ORR was 26.3%, 30.0%, 37.5%, and 15.2% in patients with anti–PD-1 failed MCC, BCC, angiosarcoma, and CSCC, respectively. The IGNYTE clinical trial cohort in NMSC is ongoing, however, enrollment was stopped in Q4 2025. ARTACUS Study: Data from the ongoing ARTACUS Phase 2 trial evaluating the potential of RP1 as monotherapy in cutaneous squamous cell carcinoma patients following organ transplant were recently presented during an oral session at the Society for Melanoma Research 22 nd International Congress. RP1 monotherapy showed robust anti-tumor activity in locally advanced CSCC with an ORR of 34.6% (CR rate was 23.1%) and 2-year duration of response of 61.0%. RP1 monotherapy was well tolerated, and the safety pro similar to that observed in non-immunocompromised patients with advanced skin cancers. RP2 REVEAL Study: The registration-directed Phase 2/3 trial of RP2 in metastatic uveal melanoma is actively enrolling. The trial is evaluating RP2 in combination with nivolumab versus ipilimumab in combination with nivolumab in approximately 280 patients. The primary endpoints of the trial are overall survival and progression free survival, and key secondary endpoints are overall response rate and disease control rate. Phase 2/3 transition is expected in Q1 2027, with PFS analysis potentially supporting accelerated approval. Liver-focused Studies: The Phase 2 clinical trial of RP2 combined with atezolizumab and bevacizumab in anti-PD-1/PD-L1 progressed hepatocellular carcinoma is currently enrolling. The protocol was amended to include RP2 as monotherapy with data planned by the end of 2026. The trial is being conducted under a collaboration and supply agreement with Roche. The Company also has enrolled its first patients in a cohort evaluating RP2 in patients with biliary tract cancer. This cohort will evaluate RP2 combined with durvalumab. Financial Highlights Cash Position : As of December 31, 2025, cash, cash equivalents and short-term investments were $269.1 million, as compared to $483.8 million as of fiscal year ended March 31, 2025. The decrease in cash balance was a result of cash burn related to operating activities in advancing the company’s clinical development plans. Based on the current operating plan, the Company believes that existing cash, cash equivalents and short-term investments will enable us to fund operations late into the first quarter of calendar 2027. This includes the potential commercialization of RP1 in skin cancers and for working capital and general corporate purposes and excludes any potential revenue. R&D Expenses: Research and development expenses were $53.1 million for the fiscal third quarter and $48.0 million for the fiscal third quarter ended December 31, 2024. This increase was primarily due to an increase in RP1 direct research costs related to the IGNYTE-3 confirmatory study and other study costs including lab and operating supplies, as well as increased RP2 study costs. In addition, personnel-related costs increased as we continued to prepare for a potential commercial launch of RP1. Research and development expenses included $3.6 million in stock-based compensation expenses for the fiscal third quarter ended December 31, 2025. S,G&A Expenses: Selling, general and administrative expenses were $18.7 million for the fiscal third quarter ended December 31, 2025, as compared to $18.0 million for the fiscal third quarter ended December 31, 2024. Selling, general and administrative expenses included $3.4 million in stock-based compensation expenses for the fiscal third quarter ended December 31, 2025. Net Loss: Net loss was $70.9 million for the fiscal third quarter ended December 31, 2025 and $66.3 million for the fiscal third quarter ended December 31, 2024. About RP1 RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response. About RP2 RP2 is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response. RP2 additionally expresses an anti-CTLA-4 antibody-like molecule, as well as GALV-GP R- and GM-CSF. RP2 is intended to provide targeted and potent delivery of these proteins to the sites of immune response initiation in the tumor and draining lymph nodes, with the goal of focusing systemic-immune-based efficacy on tumors and limiting off-target toxicity. About Replimune Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of novel oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is intended to ignite local activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to then activate a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit Forward Looking Statements This press release contains forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding our expectations about our cash runway, the status of the FDA review of our BLA for RP1 or potential approval of such BLA, the design and advancement of our clinical trials, the timing and sufficiency of our clinical trial outcomes to support potential approval of any of our product candidates, the regulatory review process and timing of potential product approval, our goals to develop and commercialize our product candidates, patient enrollments in our existing and planned clinical trials and the timing thereof, and other statements identified by words such as “could,” “expects,” “intends,” “may,” “plans,” “potential,” “should,” “will,” “would,” or similar expressions and the negatives of those terms. Forward-looking statements are not promises or guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in such forward-looking statements. These factors include risks related to the outcome of FDA’s review process, our limited operating history, our ability to generate positive clinical trial results for our product candidates, the costs and timing of operating our in-house manufacturing facility, the timing and scope of regulatory approvals, the availability of combination therapies needed to conduct our clinical trials, changes in laws and regulations to which we are subject, competitive pressures, our ability to identify additional product candidates, political and global macro factors including the impact of a global pandemic and related public health issues and the ongoing political and military conflicts, including trade conflicts, and other risks as may be detailed from time to time in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other reports we the Securities and Exchange Commission. Our actual results could differ materially from the results described in or implied by such forward-looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake no obligation to update or revise these forward-looking statements. Investor Inquiries Chris Brinzey ICR Healthcare 339.970.2843 chris.brinzey@icrhealthcare.com Media Inquiries Arleen Goldenberg Replimune 917.548.1582 media@replimune.com Replimune Group, Inc. Condensed Consolidated Statements of Operations (Amounts in thousands, except share and per share amounts) (Unaudited) Three Months Ended December 31, Nine Months Ended December 31, 2025 2024 2025 2024 Operating expenses: Research and development $ 53,140 $ 48,004 $ 168,860 $ 135,472 Selling, general and administrative 18,728 18,015 77,721 46,827 Total operating expenses 71,868 66,019 246,581 182,299 Loss from operations (71,868 ) (66,019 ) (246,581 ) (182,299 ) Other income (expense): Research and development incentives 341 376 1,138 1,222 Investment income 2,846 5,137 11,256 15,243 Interest expense on finance lease liability (514 ) (528 ) (1,553 ) (1,594 ) Interest expense on debt obligations (1,466 ) (1,450 ) (4,429 ) (4,314 ) Other (expense) income, net (580 ) (3,281 ) (865 ) (850 ) Total other income (expense), net 627 254 5,547 9,707 Loss before income taxes $ (71,241 ) $ (65,765 ) $ (241,034 ) $ (172,592 ) Income tax (benefit) provision $ (311 ) $ 575 $ (311 ) $ 575 Net loss $ (70,930 ) $ (66,340 ) $ (240,723 ) $ (173,167 ) Net loss per common share, basic and diluted $ (0.77 ) $ (0.79 ) $ (2.62 ) $ (2.25 ) Weighted average common shares outstanding, basic and diluted 92,187,581 83,498,892 91,874,481 77,113,695 Replimune Group, Inc. Condensed Consolidated Balance Sheets (Amounts In thousands, except share and per share amounts) (Unaudited) December 31, 2025 March 31, 2025 (in thousands) Consolidated Balance Sheet Data: Cash, cash equivalents and short-term investments $ 269,137 $ 483,804 Working capital 230,267 433,518 Total assets 333,590 551,328 Total stockholders' equity 210,539 415,843

Phase 2Clinical ResultPhase 3Financial StatementImmunotherapy

02 Feb 2026

·www.businesswire.com

Exelixis Announces U.S. FDA Accepted the New Drug Application for Zanzalintinib in Combination with an Immune Checkpoint Inhibitor for Patients with Metastatic Colorectal Cancer

ALAMEDA, Calif.--(BUSINESS WIRE)--Exelixis, Inc. (Nasdaq: EXEL) today announced that its New Drug Application (NDA) for zanzalintinib, in combination with atezolizumab (Tecentriq®), has been accepted for review in the U.S. for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, and, if RAS wild-type, an anti-epidermal growth factor receptor (EGFR) therapy. The Food and Drug Administration (FDA) assigned a standard review with a Prescription Drug User Fee Act target action date of December 3, 2026. “We are encouraged by this meaningful progress toward addressing the needs of patients with previously treated metastatic colorectal cancer, for whom effective therapies have been limited and treatment outcomes remain poor,” said Dana T. Aftab, Ph.D., Executive Vice President, Research and Development, Exelixis. “Zanzalintinib has the potential to become an important advancement in a challenging treatment landscape, and if approved, zanzalintinib in combination with atezolizumab would provide a novel mechanism of action for patients with previously treated metastatic colorectal cancer. We are deeply grateful to the patients, caregivers and investigators contributing to the clinical research in support of this application, and we look forward to collaborating with the FDA during the review process for our first NDA for zanzalintinib.” The NDA is based on the results of the phase 3 STELLAR-303 pivotal trial, in which zanzalintinib in combination with atezolizumab demonstrated a statistically significant improvement in overall survival (OS) versus regorafenib in the intention-to-treat (ITT) population of patients with previously treated CRC. Detailed results, including OS and progression-free survival (PFS) in the ITT population and in the subset of patients without liver metastases (non-liver metastases, NLM), were presented at the 2025 European Society for Medical Oncology (ESMO) Congress and published in The Lancet. Data pertaining to the other dual primary endpoint, OS in patients without active liver metastases, were immature at the data cutoff, and the trial is proceeding to the planned final analysis for this endpoint, which is expected in mid-2026, based on current event rates. About STELLAR-303 STELLAR-303 (NCT05425940) is a global, multicenter, randomized, phase 3, open-label study that randomized patients 1:1 to either zanzalintinib in combination with atezolizumab (n=451) or regorafenib (n=450). The study includes patients with previously treated non-MSI-high metastatic CRC. The dual primary endpoints of the study are OS in the ITT population and in the NLM subgroup of patients. The ITT population consisted of all randomized patients, regardless of the presence of liver metastases. The NLM subgroup consisted of patients who did not have active liver metastases at baseline as determined by investigator assessment. Secondary endpoints include PFS, objective response rate and duration of response in the ITT population and in the NLM subgroup of patients. More information about the trial is available at ClinicalTrials.gov. About Zanzalintinib Zanzalintinib is a novel oral kinase inhibitor that inhibits the activity of the TAM kinases (TYRO3, AXL, MER), MET and VEGF receptors. These kinases play important roles in oncogenic processes, including tumor cell proliferation, metastasis, angiogenesis, drug resistance and evasion of antitumor immunity. With zanzalintinib, Exelixis sought to build upon its extensive experience with the target profile of cabozantinib, the company’s flagship medicine, while improving key characteristics, including pharmacokinetic half-life. Zanzalintinib is currently being developed for the treatment of advanced solid tumors, including colorectal cancer, kidney cancer and neuroendocrine tumors. Zanzalintinib is an investigational agent that is not approved for any use and is the subject of ongoing clinical trials. About CRC CRC is the third most common cancer and a leading cause of cancer-related deaths in the U.S.1 Approximately 159,000 new cases will be diagnosed in the U.S. in 2026, with around 55,000 expected deaths from the disease.1 CRC is most frequently diagnosed among people aged 65-74 and is more common in men and in people of non-Hispanic American Indian/Alaska Native descent.2 Nearly a quarter of CRC cases are diagnosed at the metastatic stage, at which point the five-year survival rate is around just 15%.1,2 The liver is the most common site for CRC metastasis. Liver metastases significantly impact survival, with a median five-year survival rate of less than 14% when treated with palliative chemotherapy.3 About Exelixis Exelixis is a globally ambitious oncology company innovating next-generation medicines and regimens at the forefront of cancer care. Powered by drug discovery and development excellence, we are rapidly evolving our product portfolio to target an expanding range of tumor types and indications with our clinically differentiated pipeline of small molecules and biotherapeutics. This comprehensive approach harnesses decades of robust investment in our science and partnerships to advance our pipeline of franchise molecules, including our novel oral kinase inhibitor zanzalintinib, and to extend the impact of our flagship commercial product, CABOMETYX® (cabozantinib). Exelixis is driven by a bold scientific pursuit to create transformational treatments that give more patients hope for the future. For information about the company and its mission to help cancer patients recover stronger and live longer, visit www.exelixis.com, follow @ExelixisInc on X (Twitter), like Exelixis, Inc. on Facebook and follow Exelixis on LinkedIn. Forward-Looking Statements This press release contains forward-looking statements, including, without limitation, statements related to: the therapeutic potential of zanzalintinib, in combination with atezolizumab, as a treatment for patients with previously treated mCRC; the regulatory review process, including the PDUFA target action date assigned by the FDA, and Exelixis’ plans to collaborate with the FDA while the application is reviewed; and Exelixis’ scientific pursuit to create transformational treatments that give patients more hope for the future. Any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements and are based upon Exelixis’ current plans, assumptions, beliefs, expectations, estimates and projections. Forward-looking statements involve risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result of these risks and uncertainties, which include, without limitation: complexities and the unpredictability of the regulatory review and approval processes in the U.S. and elsewhere, including the risk that the FDA may not approve the combination of zanzalintinib with atezolizumab as a treatment for patients with previously treated mCRC in a timely fashion, if at all; unexpected concerns that may arise as a result of the occurrence of adverse safety events or additional data analyses of clinical trials evaluating zanzalintinib and/or atezolizumab; Exelixis’ ability to protect its intellectual property rights; market competition; changes in economic and business conditions; and other factors affecting the ability of Exelixis to obtain regulatory approval for zanzalintinib in new indications detailed from time to time under the caption “Risk Factors” in Exelixis’ most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, and in Exelixis’ future filings with the Securities and Exchange Commission. All forward-looking statements in this press release are based on information available to Exelixis as of the date of this press release, and Exelixis undertakes no obligation to update or revise any forward-looking statements contained herein, except as required by law. Exelixis, the Exelixis logo and CABOMETYX are registered U.S. trademarks of Exelixis. TECENTRIQ is a registered U.S. trademark of Genentech, a member of the Roche Group. ____________________ 1 Cancer Facts & Figures 2026. ACS website. Available at: https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2026/2026-cancer-facts-and-figures.pdf. Accessed February 2026. 2 Cancer Stat Facts: Colorectal Cancer. SEER website. Available at: https://seer.cancer.gov/statfacts/html/colorect.html. Accessed February 2026. 3 Ros J, Salva F, Dopazo C, et al. Liver transplantation in metastatic colorectal cancer: are we ready for it? Br J Cancer. May 2023;128(10):1797-1806.

Phase 3Clinical ResultNDAPriority ReviewPhase 2

02 Feb 2026

·ir.exelixis.com

Exelixis Announces U.S. FDA Accepted the New Drug Application for Zanzalintinib in Combination with an Immune Checkpoint Inhibitor for Patients with Metastatic Colorectal Cancer

– The FDA assigned a Prescription Drug User Fee Act target action date of December 3, 2026 – – Application is based on results from the phase 3 STELLAR-303 pivotal trial, in which zanzalintinib in combination with atezolizumab improved median overall survival and significantly reduced the risk of death versus regorafenib in the intention-to-treat population – ALAMEDA, Calif. --(BUSINESS WIRE)--Feb. 2, 2026-- Exelixis, Inc. (Nasdaq: EXEL) today announced that its New Drug Application (NDA) for zanzalintinib, in combination with atezolizumab (Tecentriq®), has been accepted for review in the U.S. for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, and, if RAS wild-type, an anti-epidermal growth factor receptor (EGFR) therapy. The Food and Drug Administration (FDA) assigned a standard review with a Prescription Drug User Fee Act target action date of December 3, 2026 . “We are encouraged by this meaningful progress toward addressing the needs of patients with previously treated metastatic colorectal cancer, for whom effective therapies have been limited and treatment outcomes remain poor,” said Dana T. Aftab , Ph.D., Executive Vice President, Research and Development , Exelixis . “Zanzalintinib has the potential to become an important advancement in a challenging treatment landscape, and if approved, zanzalintinib in combination with atezolizumab would provide a novel mechanism of action for patients with previously treated metastatic colorectal cancer. We are deeply grateful to the patients, caregivers and investigators contributing to the clinical research in support of this application, and we look forward to collaborating with the FDA during the review process for our first NDA for zanzalintinib.” The NDA is based on the results of the phase 3 STELLAR-303 pivotal trial, in which zanzalintinib in combination with atezolizumab demonstrated a statistically significant improvement in overall survival (OS) versus regorafenib in the intention-to-treat (ITT) population of patients with previously treated CRC. Detailed results, including OS and progression-free survival (PFS) in the ITT population and in the subset of patients without liver metastases (non-liver metastases, NLM), were presented at the 2025 European Society for Medical Oncology (ESMO) Congress and published in The Lancet . Data pertaining to the other dual primary endpoint, OS in patients without active liver metastases, were immature at the data cutoff, and the trial is proceeding to the planned final analysis for this endpoint, which is expected in mid-2026, based on current event rates. About STELLAR-303 STELLAR-303 (NCT05425940) is a global, multicenter, randomized, phase 3, open-label study that randomized patients 1:1 to either zanzalintinib in combination with atezolizumab (n=451) or regorafenib (n=450). The study includes patients with previously treated non-MSI-high metastatic CRC. The dual primary endpoints of the study are OS in the ITT population and in the NLM subgroup of patients. The ITT population consisted of all randomized patients, regardless of the presence of liver metastases. The NLM subgroup consisted of patients who did not have active liver metastases at baseline as determined by investigator assessment. Secondary endpoints include PFS, objective response rate and duration of response in the ITT population and in the NLM subgroup of patients. More information about the trial is available at ClinicalTrials.gov. About Zanzalintinib Zanzalintinib is a novel oral kinase inhibitor that inhibits the activity of the TAM kinases (TYRO3, AXL, MER), MET and VEGF receptors. These kinases play important roles in oncogenic processes, including tumor cell proliferation, metastasis, angiogenesis, drug resistance and evasion of antitumor immunity. With zanzalintinib, Exelixis sought to build upon its extensive experience with the target profile of cabozantinib, the company’s flagship medicine, while improving key characteristics, including pharmacokinetic half-life. Zanzalintinib is currently being developed for the treatment of advanced solid tumors, including colorectal cancer, kidney cancer and neuroendocrine tumors. Zanzalintinib is an investigational agent that is not approved for any use and is the subject of ongoing clinical trials. About CRC CRC is the third most common cancer and a leading cause of cancer-related deaths in the U.S. 1 Approximately 159,000 new cases will be diagnosed in the U.S. in 2026, with around 55,000 expected deaths from the disease.1 CRC is most frequently diagnosed among people aged 65-74 and is more common in men and in people of non-Hispanic American Indian/Alaska Native descent.2 Nearly a quarter of CRC cases are diagnosed at the metastatic stage, at which point the five-year survival rate is around just 15%.1,2 The liver is the most common site for CRC metastasis. Liver metastases significantly impact survival, with a median five-year survival rate of less than 14% when treated with palliative chemotherapy.3 About Exelixis Exelixis is a globally ambitious oncology company innovating next-generation medicines and regimens at the forefront of cancer care. Powered by drug discovery and development excellence, we are rapidly evolving our product portfolio to target an expanding range of tumor types and indications with our clinically differentiated pipeline of small molecules and biotherapeutics. This comprehensive approach harnesses decades of robust investment in our science and partnerships to advance our pipeline of franchise molecules, including our novel oral kinase inhibitor zanzalintinib, and to extend the impact of our flagship commercial product, CABOMETYX® (cabozantinib). Exelixis is driven by a bold scientific pursuit to create transformational treatments that give more patients hope for the future. For information about the company and its mission to help cancer patients recover stronger and live longer, visit www.exelixis.com, follow @ExelixisInc on X (Twitter), like Exelixis, Inc. on Facebook and follow Exelixis on LinkedIn. Forward-Looking Statements This press release contains forward-looking statements, including, without limitation, statements related to: the therapeutic potential of zanzalintinib, in combination with atezolizumab, as a treatment for patients with previously treated mCRC; the regulatory review process, including the PDUFA target action date assigned by the FDA, and Exelixis’ plans to collaborate with the FDA while the application is reviewed; and Exelixis’ scientific pursuit to create transformational treatments that give patients more hope for the future. Any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements and are based upon Exelixis’ current plans, assumptions, beliefs, expectations, estimates and projections. Forward-looking statements involve risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result of these risks and uncertainties, which include, without limitation: complexities and the unpredictability of the regulatory review and approval processes in the U.S. and elsewhere, including the risk that the FDA may not approve the combination of zanzalintinib with atezolizumab as a treatment for patients with previously treated mCRC in a timely fashion, if at all; unexpected concerns that may arise as a result of the occurrence of adverse safety events or additional data analyses of clinical trials evaluating zanzalintinib and/or atezolizumab; Exelixis’ ability to protect its intellectual property rights; market competition; changes in economic and business conditions; and other factors affecting the ability of Exelixis to obtain regulatory approval for zanzalintinib in new indications detailed from time to time under the caption “Risk Factors” in Exelixis’ most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, and in Exelixis’ future filings with the Securities and Exchange Commission. All forward-looking statements in this press release are based on information available to Exelixis as of the date of this press release, and Exelixis undertakes no obligation to update or revise any forward-looking statements contained herein, except as required by law. Exelixis , the Exelixis logo and CABOMETYX are registered U.S. trademarks of Exelixis . TECENTRIQ is a registered U.S. trademark of Genentech , a member of the Roche Group. View source version on businesswire.com: https://www.businesswire.com/news/home/20260130221586/en/ Investors Contact: Andrew Peters SVP, Strategy and Investor Relations Exelixis, Inc. 650-837-7248 apeters@exelixis.com Media Contact: Stekki Millman Senior Director, Public Affairs Exelixis, Inc. 650-837-7187 smillman@exelixis.com Source: Exelixis, Inc.

Clinical ResultPhase 3NDA

100 Deals associated with Atezolizumab

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KEGG	Wiki	ATC	Drug Bank
D10773	Atezolizumab	L01XC32	DB11595

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Extranodal NK-T-Cell Lymphoma	Japan	Chugai Pharmaceutical Co., Ltd.	19 Sep 2025
Advanced Lung Non-Small Cell Carcinoma	European Union	Roche Registration GmbH	25 Jul 2024
Advanced Lung Non-Small Cell Carcinoma	Iceland	Roche Registration GmbH	25 Jul 2024
Advanced Lung Non-Small Cell Carcinoma	Liechtenstein	Roche Registration GmbH	25 Jul 2024
Advanced Lung Non-Small Cell Carcinoma	Norway	Roche Registration GmbH	25 Jul 2024
Breast Cancer	Canada	F. Hoffmann-La Roche Ltd.	13 Mar 2024
Alveolar Soft Part Sarcoma	United States	Genentech, Inc.	09 Dec 2022
PD-L1 positive Non-Small Cell Lung Cancer	Japan	Chugai Pharmaceutical Co., Ltd.	26 May 2022
BRAF V600 mutation-positive Melanoma	United States	Genentech, Inc.	30 Jul 2020
PD-L1 positive Triple Negative Breast Cancer	Japan	Chugai Pharmaceutical Co., Ltd.	19 Jan 2018
Advanced Hepatocellular Carcinoma	European Union	Roche Registration GmbH	20 Sep 2017
Advanced Hepatocellular Carcinoma	Iceland	Roche Registration GmbH	20 Sep 2017
Advanced Hepatocellular Carcinoma	Liechtenstein	Roche Registration GmbH	20 Sep 2017
Advanced Hepatocellular Carcinoma	Norway	Roche Registration GmbH	20 Sep 2017
Advanced Triple-Negative Breast Carcinoma	European Union	Roche Registration GmbH	20 Sep 2017
Advanced Triple-Negative Breast Carcinoma	Iceland	Roche Registration GmbH	20 Sep 2017
Advanced Triple-Negative Breast Carcinoma	Liechtenstein	Roche Registration GmbH	20 Sep 2017
Advanced Triple-Negative Breast Carcinoma	Norway	Roche Registration GmbH	20 Sep 2017
Extensive stage Small Cell Lung Cancer	European Union	Roche Registration GmbH	20 Sep 2017
Extensive stage Small Cell Lung Cancer	Iceland	Roche Registration GmbH	20 Sep 2017

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Muscle Invasive Bladder Carcinoma	NDA/BLA	Japan	Chugai Pharmaceutical Co., Ltd.	28 Jan 2026
Bladder Cancer	NDA/BLA	China	Roche Holding AG	25 Feb 2019
Lymphoproliferative Disorders	Phase 3	United Kingdom	Hoffmann-La Roche Ltd.	25 Oct 2023
Melanoma	Phase 3	United Kingdom	Hoffmann-La Roche Ltd.	25 Oct 2023
Microsatellite instability-high cancer	Phase 3	United Kingdom	Hoffmann-La Roche Ltd.	25 Oct 2023
Turcot Syndrome	Phase 3	United Kingdom	Hoffmann-La Roche Ltd.	25 Oct 2023
Locally advanced breast cancer	Phase 3	United States	Roche China Holding Ltd.	29 Mar 2021
Locally advanced breast cancer	Phase 3	United States	F. Hoffmann-La Roche Ltd.	29 Mar 2021
Locally advanced breast cancer	Phase 3	United States	Roche Diagnostics GmbH	29 Mar 2021
Locally advanced breast cancer	Phase 3	Australia	Roche China Holding Ltd.	29 Mar 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05746481 (CTgov)	Phase 2	Metastatic Non-Squamous Non-Small Cell Lung Carcinoma \| Non-squamous non-small cell lung cancer \| Brain metastases	3	Carboplatin+Pemetrexed+Atezolizumab+Tiragolumab	twvgzqqfcq = bnwqfnveyv hqiwenasrf (imrecaruif, aszxzfjhph - obxntemubx) View more	-	22 Jan 2026
NCT05009069 (NEOTERIC, Pubmed \| NEWS \| J Clin Oncol) Manual	Phase 2	Locally Advanced Rectal Carcinoma Neoadjuvant	55	Atezolizumab + Tiragolumab	qewzzpmxvh(ihphtshlaf) = tvbmexpxlr anwzppsdxh (ymmyrticmc, 18.6 - 55.9) View more	Positive	13 Jan 2026
				Atezolizumab	qewzzpmxvh(ihphtshlaf) = vnriyqgjio anwzppsdxh (ymmyrticmc, 8.6 - 42.3) View more
NCT03811002 (NRG Oncology/Alliance LU005, Pubmed \| J Clin Oncol)	Phase 3	Small cell lung cancer limited stage	398	Concurrent chemoradiation + concurrent and adjuvant atezolizumab	wrdhobavla(kkxbxhsiul) = kxsbaqdlvv kejkousmaj (kimmpwkxdc, 28.5 - 44.7) View more	Negative	13 Jan 2026
				Concurrent chemoradiation alone	wrdhobavla(kkxbxhsiul) = xjqxpdhjww kejkousmaj (kimmpwkxdc, 28.1 - 42.5) View more
NCT07280377 (GOBLET, Company_Website) Manual	Phase 1/2	Anus Neoplasms Third line	14	Pelareorep + Atezolizumab	gvcjwlnawd(umodcpqqzf) = dycsylfuor xrnezrxltk (bcksldrvmz ) View more	Positive	12 Jan 2026
NCT04770272 (neoMono, CTgov)	Phase 2	Triple Negative Breast Cancer	442	Biopsy Arm A+Cyclophosphamide+Carboplatin+Paclitaxel+Atezolizumab 840 MG in 14 ML Injection+epirubicin (Arm A)	swfrouwpbx = lrxikjqezr ewarvybdcs (ulyknjsqyh, ttxjslshgl - gsemgqwmvg) View more	-	12 Jan 2026
				Biopsy Arm B+Cyclophosphamide+Carboplatin+Paclitaxel+Atezolizumab 1200 MG in 20 ML Injection+epirubicin (Arm B)	swfrouwpbx = xcjwclgjbl ewarvybdcs (ulyknjsqyh, hxxyhppfin - ewfafzjbwu) View more
ASCO_GI2026	Not Applicable	Unresectable Hepatocellular Carcinoma First line	47	Atezolizumab + Bevacizumab	uztfplwxfb(thjesoribs) = mmxmtpxqgp yclmmidwbd (xnqggioycj, 4.9 - 21.08) View more	Positive	08 Jan 2026
IMbrave150 (ASCO_GI2026)	Phase 2/3	Advanced Hepatocellular Carcinoma First line	1,064	Tremelimumab + Durvalumab	jekamrwmmx(aykgmhiowt) = kelsnyquci asneflczon (cadamhltgp ) View more	Positive	08 Jan 2026
				Atezolizumab + Bevacizumab	jekamrwmmx(aykgmhiowt) = sbmrnmuhwk asneflczon (cadamhltgp ) View more
ASCO_GI2026	Not Applicable	Advanced Hepatocellular Carcinoma First line	1,442	Atezolizumab plus bevacizumab (A+B)	xdnceilmff(xgauoyhxwk) = rpmxjgazwh eucfvgujpp (hjgrvhvasl ) View more	Positive	08 Jan 2026
				Lenvatinib (L)	xdnceilmff(xgauoyhxwk) = ljylnnbcwp eucfvgujpp (hjgrvhvasl ) View more
NCT06294548 (ASCO_GI2026)	Phase 1/2	Advanced Hepatocellular Carcinoma First line	27	Valemetostat tosylate (DS-3201b)BevacizumabAtezolizumab tosylate (DS-3201b) + Valemetostat tosylate (DS-3201b)BevacizumabAtezolizumab + Valemetostat tosylate (DS-3201b)BevacizumabAtezolizumab	hdxogpsmjb(nrieoyymec) = lozqnbroyk xbevnewmcq (oavubextmb ) View more	Positive	08 Jan 2026
NCT05733598 (RP2-003, ASCO_GI2026)	Phase 2	Advanced biliary tract cancer \| Advanced Hepatocellular Carcinoma Second line \| First line	60	RP2 + Atezolizumab + Bevacizumab	uyjydqvodr(kryfkmexwu) = toukucgmrk kmoefiblir (cqvxzytkjl )	Positive	08 Jan 2026
				RP2 + Durvalumab	uyjydqvodr(hhosahfmev) = rsencbooud uqvffrcfpa (fzkgdcgfsk )

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