A Randomized, Open-label, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of IBI363 in Combination With Bevacizumab Versus Investigator's Choice of Therapy in Participants With Advanced Colorectal Cancer Who Have Failed or Are Intolerant to Standard Care of Therapy

This is an open-label, multicenter Phase 3 study to evaluate the safety and tolerability of IBI363 plus bevacizumab in patients with advanced colorectal cancer refractory or intolerant to standard-of-care therapy

Start Date31 Jul 2026

Sponsor / Collaborator

Innovent Biologics (Suzhou) Co. Ltd.

NCT07535632

/ Not yet recruitingPhase 2IIT

A Phase II Clinical Study on the Efficacy of Stereotactic Body Radiation Therapy Sequential Combined With Bevacizumab and Trifluridine/Tipiracil in the Treatment of Recurrent Metastatic Colorectal Cancer(BEST)

This phase II trial studies how well stereotactic body radiotherapy (SBRT) followed by a combination of an immune checkpoint inhibitor (sintilimab), bevacizumab, and trifluridine/tipiracil (TAS-102) works as third-line treatment for patients with recurrent or metastatic colorectal cancer (mCRC) that has progressed after at least two prior lines of systemic therapy.
The study will enroll 58 participants at Zhongshan Hospital, Fudan University. Participants will be randomly assigned (1:1) to either the experimental group or the control group. Those in the experimental group will receive SBRT to lung or liver metastases, followed one week later by sintilimab (200 mg every 2 weeks), bevacizumab (5 mg/kg every 2 weeks), and TAS-102 (35 mg/m² twice daily on days 1-5 every 2 weeks). Those in the control group will receive the investigator's choice of standard third-line therapy (such as TAS-102 alone or with bevacizumab, regorafenib, or fruquintinib).
The main purpose is to see whether the new combination extends the time without the cancer growing or spreading (progression-free survival, PFS). Other goals include measuring overall survival, tumor response rates, local control of treated tumors, abscopal (out-of-field) effects, safety, quality of life, and exploring biomarkers that might predict treatment response.
The study is expected to take 24 months to complete (12 months for enrollment and 12 months for follow-up). Results will help determine if adding SBRT and immunotherapy to standard chemotherapy and anti-angiogenic therapy is a beneficial option for patients with refractory mCRC.

Start Date01 Jun 2026

Sponsor / Collaborator

Zhongshan Hospital Fudan University

[+1]

NCT07612137

/ Not yet recruitingPhase 1/2

A Phase Ib/II Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of IBI3005 Combination Therapy in Participants With Advanced Solid Tumors

To evaluate the safety and tolerability of IBI3005 combination therapy in participants with advanced solid tumors; to evaluate the antitumor activity of IBI3005 combination therapy in participants with advanced solid tumors.

Start Date01 Jun 2026

Sponsor / Collaborator

Innovent Biologics (Suzhou) Co. Ltd.

100 Clinical Results associated with Bevacizumab biosimilar (Innovent Biologics)

100 Translational Medicine associated with Bevacizumab biosimilar (Innovent Biologics)

100 Patents (Medical) associated with Bevacizumab biosimilar (Innovent Biologics)

Literatures (Medical) associated with Bevacizumab biosimilar (Innovent Biologics)

01 Oct 2026·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

Integrating multiple outcomes of first-line immunotherapy-based regimens for advanced hepatocellular carcinoma: A network meta-analysis of phase III trials

Review

Author: Li, Xinming ; Kong, Qingyan ; Xu, Jianrong ; Nie, Guilin ; Yang, Jiaqi ; Liu, Geng ; Wang, Yaoqun ; Li, Bei ; Lu, Jiong

BACKGROUND:

Immunotherapy-based regimens are standard first-line treatments for advanced hepatocellular carcinoma (HCC), yet integrated comparisons across efficacy, safety, and quality-of-life (QoL) outcomes remain limited. We performed a network meta-analysis (NMA) to identify the optimal treatment strategy.

METHODS:

A literature search was conducted in PubMed, Embase, Cochrane Library, and Scopus to identify phase III randomized controlled trials (RCTs) evaluating immune checkpoint inhibitor (ICI)-based therapies. A Bayesian network meta-analysis was conducted to compare overall survival (OS), progression-free survival (PFS), tumor response, safety and QoL, with treatment rankings estimated using surface under the cumulative ranking curve (SUCRA) values. A subgroup analysis was conducted. A multi-criteria decision making approach, entropy-weighted Technique for Order Preference by Similarity to Ideal Solution (TOPSIS) model was conducted to integrate efficacy, safety, and health-related QoL outcomes RESULTS: Twelve RCTs involving 7908 patients met inclusion criteria. Sintilimab plus IBI305 showed the highest probability of being the most effective treatment for overall survival with highest SUCRA scores (0.91). Finotonlimab plus bevacizumab was most likely to improve overall survival in younger patients (0.95) and those with HBV-related HCC (0.84), as well as PFS in the overall population (0.86). When integrating efficacy, safety, and health-related QoL outcomes, finotonlimab plus bevacizumab and atezolizumab plus bevacizumab demonstrated superior overall performance compared with all other regimens.

CONCLUSIONS:

Bevacizumab-based immunotherapy combinations (finotonlimab plus bevacizumab and atezolizumab plus bevacizumab) provide a favorable benefit-risk balance in advanced HCC. The robust performance of finotonlimab plus bevacizumab highlights its translational potential. Composite points such as Topsis may facilitate integrated multiple outcomes.

01 Mar 2026·Liver International

Comparing of Efficacy and Safety Between Sintilimab Plus IBI305 and PD ‐1 Inhibitor Plus TKIs in Combination of TACE for uHCC

Article

Author: Zhou, Yi ; Qin, Huixia ; Wang, Kai ; Ya, Houxiang ; Jiang, Kaiwen ; Liu, Chengyuan ; Gu, Jing ; Lin, Hesheng ; Li, Shuqun

ABSTRACT:

Background:

Systemic therapy combined with transcatheter arterial chemoembolization (TACE) is the main treatment strategy for patients with unresectable hepatocellular carcinoma (uHCC). Nevertheless, there are currently few direct comparative studies between different combined treatment regimens. Therefore, this study aims to compare the efficacy and safety of sintilimab and bevacizumab biosimilar (IBI305) versus PD‐1 inhibitor and tyrosine kinase inhibitor (TKI) combined with TACE in the treatment of uHCC.

Methods:

This retrospective study included 225 patients with uHCC who received either TACE combined with sintilimab and IBI305 (TSB group, n = 84) or other PD‐1 inhibitors and TKIs (TTP group, n = 141). This study evaluated overall survival (OS) as the primary outcome, with secondary endpoints encompassing progression‐free survival (PFS), objective response rate (ORR), disease control rate (DCR)and treatment‐related adverse events (TRAEs). To mitigate potential confounding biases across the two cohorts, propensity score matching (PSM) was employed.

Results:

Following PSM, 136 uHCC patients were included, with 68 in both the TSB and TTP groups. There was no statistical difference in OS ( p = 0.18) or PFS ( p = 0.34) between the TSB group and the TTP group. According to both RECIST1.1 and mRECIST criteria, there were no notable changes in ORR or DCR. Both groups demonstrated manageable toxicity profiles. Subgroup analysis suggested that whereas patients with large tumours (HR, 0.33; p = 0.024), solitary lesions (HR, 0.16; p < 0.001) or portal vein tumour thrombosis (HR, 0.43; p = 0.033) derived greater survival benefit from the TSB regimen, those with multifocal tumours (HR, 1.86; p = 0.033) benefited more from the TTP regimen.

Conclusions:

The TSB and TTP regimens offer comparable efficacy and safety in uHCC, yet the TSB regimen appears to offer greater benefit in specific patient subgroups.

01 Jan 2026·BMJ Open

CapeOX (capecitabine and oxaliplatin) combined with sintilimab and bevacizumab biosimilar (IBI305) for first-line treatment of advanced gastric or oesophagogastric junction adenocarcinoma: study protocol for a single-arm, phase Ib/II trial

Article

Author: Dai, Ruihong ; Zhou, Jitao ; Liu, Ming ; Bi, Feng ; Zhang, Pengfei ; Cheng, Mo

Background:

A combination of chemotherapy and immune checkpoint inhibitor therapy has been demonstrated to be effective as a first-line treatment of gastric or gastro-oesophageal junction (G/GEJ) cancer. The conventional treatment strategy for patients with advanced/metastatic human epidermal growth factor receptor 2-negative G/GEJ cancer is recommended. However, the response rate and enhancements in survival are still significantly insufficient. The present study will investigate the efficacy and safety of incorporating a bevacizumab biosimilar IBI305 into chemotherapy and immunotherapy as a first-line treatment for advanced or metastatic G/GEJ cancer.

Methods and analysis:

This single-arm, open-label, prospective phase Ib/II clinical study will involve 57 participants. In phase Ib of the trial, patients with advanced or metastatic G/GEJ cancer will receive capecitabine and oxaliplatin (CapeOX) together with sintilimab (200 mg intravenously every 3 weeks) and IBI305 (7.5, 10 or 15 mg/kg intravenously every 3 weeks) in a 3+3 dose-escalation design to evaluate dose-limiting toxicities (DLTs) within 6 weeks of treatment initiation. In phase II, the patients will receive CapeOX combined with sintilimab and IBI305 at the recommended phase II dose. The primary objectives will be to assess DLTs (phase Ib) and the objective response rate (phase II). The secondary objectives will include progression-free survival, overall survival, disease control rate, duration of response, adverse effects, quality of life and safety.

Ethics and dissemination:

The trial protocol was approved by the Ethics Committee of West China Hospital and ClinicalTrials. The final results will be published in a peer-reviewed journal upon completion of the study.

Trial registration number:

NCT05640609 .

155

News (Medical) associated with Bevacizumab biosimilar (Innovent Biologics)

06 Aug 2026

·www.prnewswire.com

Innovent Announces First Patient Dosed in Pivotal Registrational Study of IBI363/TAK-928 (PD-1/IL-2α-biased Bispecific Fusion Protein) in Combination with Bevacizumab in Late-Line Advanced Colorectal Cancer in China

SAN FRANCISCO and SUZHOU, China, Aug. 5, 2026 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures, and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology, and other major diseases, announced that the first patient has been dosed in a pivotal study evaluating IBI363 (Takeda R&D code: TAK-928), a potential first-in-class PD-1/IL-2α-biased bispecific fusion protein, in combination with bevacizumab versus investigator's choice of therapy, in patients with advanced colorectal cancer (CRC) that is refractory or intolerant to standard treatment. This is the third pivotal registrational clinical study initiated for IBI363 and marks a critical step forward for investigational next-generation immuno-oncology (IO) therapies in overcoming colorectal cancer—a classic 'immune-cold' tumor. Previously initiated studies of IBI363 include a pivotal Phase 2 clinical study (NCT07217301) in China for IO-naïve melanoma (acral and mucosal subtypes). A global, multi-center, Phase 3 clinical study (NCT06797297) in IO-resistant squamous non-small cell lung cancer (NSCLC) has also been initiated. As part of a license and collaboration agreement, Innovent and Takeda are co-developing IBI363/TAK-928 globally and will co-commercialize IBI363/TAK-928 in the U.S. Takeda will exclusively commercialize IBI363/TAK-928 worldwide outside of the U.S. and greater China. This trial (NCT07722494) is a multicenter, randomized, open-label, Phase 3 clinical study designed to evaluate the efficacy and safety of IBI363 in combination with bevacizumab compared with investigator's choice of therapy in patients with advanced colorectal cancer who have failed or are intolerant to standard therapies. A total of 550 patients are planned to be enrolled. The primary endpoint of this study is overall survival (OS). This study is being conducted in China where Innovent holds development and commercialization rights for IBI363/TAK-928. At the 2025 ASCO Annual Meeting, data from a Phase 1 clinical study of IBI363 for the treatment of advanced colorectal cancer was presented as an oral presentation. IBI363 in combination with bevacizumab demonstrated encouraging efficacy signals and a manageable safety profile. [ link ] Among patients treated with IBI363 in combination with bevacizumab (n=73), the overall confirmed objective response rate (cORR) was 15.1%, and the disease control rate (DCR) was 61.6%. With a median follow-up of 9.9 months, the progression-free survival (PFS) reached 4.7 months. With a median follow-up of 9.4 months, overall survival (OS) data remained immature, with only 13 events (17.8%) observed. The overall safety profile was clinically manageable, and no new safety signals were observed. The incidence of Grade 3 or higher treatment-related adverse events (TRAEs) in the combination therapy group was 35.6%. The most common TRAEs were arthralgia, anemia, rash, and hypothyroidism. Based on updated long-term follow-up data from the above study, IBI363 in combination with bevacizumab was granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) in May 2026. The proposed indication is for patients with advanced microsatellite stable (MSS) or mismatch repair-proficient (pMMR) colorectal cancer (CRC) who have progressed on ≥ 2 lines of prior standard therapy. The updated study results are planned for presentation at a future international academic conference or publication in an international academic journal. Professor Kefeng Ding from the Second Affiliated Hospital of Zhejiang University School of Medicine, the principal investigator of this study, stated: "Colorectal cancer is a common gastrointestinal malignancy that poses a severe threat to human health. Worldwide, it ranks third in incidence and second in mortality among all malignant tumors[1]. Approximately 86% of colorectal cancers are in an immune-desert or immune-suppressed state, rendering them unresponsive to traditional immune checkpoint inhibitors (ICIs)[2]. For patients with colorectal cancer who have failed standard therapy, treatment options are limited, survival is short, and there remains a huge unmet clinical need[3-5]. As a PD-1/IL-2α-biased bispecific molecule, IBI363's dual antitumor mechanism—blocking PD-1 while stimulating tumor-specific CD8⁺ T cells (TST cells)—holds the promise of turning 'cold' tumors 'hot'. Early data for IBI363 in combination with bevacizumab in late-line treatment have demonstrated encouraging, breakthrough efficacy along with tolerable safety, showing potential to become a novel immunotherapy for colorectal cancer. I will work closely with other investigators to advance and complete this pivotal clinical study, steadily generating high-quality clinical data to provide colorectal cancer patients with a more effective treatment option." Professor Tao Zhang from Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, the principal investigator of this study, stated: "For patients with advanced colorectal cancer (CRC), treatment options become extremely limited after the failure of second-line or later therapies. In particular, patients with MSS CRC—who represent the vast majority of colorectal cancer cases—are largely insensitive to current immune checkpoint inhibitors. Chemotherapy or anti-angiogenic agents offer limited efficacy and fail to deliver durable disease control, leaving patients in urgent need of effective late-line treatment options. IBI363, featuring a unique PD-1/IL-2α-biased dual immuno-activation mechanism, holds the potential to overcome the immunosuppressive state of 'cold tumors.' The early clinical data for IBI363 in combination with bevacizumab are highly encouraging. As a clinician, I look forward to the initiation and progress of the Phase 3 clinical study, hoping it will soon bring meaningful treatment choices and renewed hope of survival to patients with late-line colorectal cancer." Dr. Hui Zhou, Chief R&D Officer (Oncology) of Innovent, stated: "IBI363 represents the evolutionary direction of next-generation immunotherapy—not only potentially improving on the survival benefits of existing IO therapies, but also striving to overcome 'cold' tumors that traditional IO treatments cannot effectively address. Early clinical data demonstrate that IBI363 in combination with bevacizumab achieves significant responses and long-term survival benefits in non-MSI-H/pMMR advanced colorectal cancer, validating its unique mechanism and broad-spectrum potential. Currently, the first batch of core indications for IBI363 has smoothly entered pivotal registration clinical trials. We look forward to offering a new choice for colorectal cancer patients and bringing hope to broader unaddressed areas in immunotherapy." About MSS/pMMR Colorectal Cancer Colorectal cancer (CRC) is one of the most common malignancies worldwide, with MSS/pMMR being the predominant subtype, accounting for approximately 95% of advanced CRC cases. For patients with advanced MSS/pMMR CRC who have failed standard therapies, there remains a significant unmet medical need. Treatment options are limited, and prognosis remains poor (mPFS 1.9~5.6 months, mOS 6.4~10.8 months[3-5]). About IBI363/TAK-928 (PD-1/IL-2α-biased bispecific fusion protein) IBI363 is a first-in-class PD-1/IL-2α-biased bispecific antibody fusion protein being co-developed by Innovent Biologics and Takeda (Takeda R&D code: TAK-928). It functions by both blocking the PD-1/PD-L1 pathway and activating the IL-2 pathway. The IL-2 arm of IBI363 is designed to maintain its affinity for IL-2Rα while reducing binding to IL-2Rβ and IL-2Rγ, thereby minimizing toxicity. The PD-1 binding arm not only blocks PD-1 but also selectively delivers IL-2. This approach targets and activates tumor-specific T cells that express both PD-1 and IL-2α, leading to more precise and effective activation of this T cell subpopulation. IBI363 is being evaluated in a series of clinical trials globally, including: A pivotal Phase 2 study in China in previously untreated acral and mucosal melanoma A global, multi-center Phase 3 study in immunotherapy-resistant squamous NSCLC A pivotal Phase 3 study in China in advanced CRC refractory or intolerant to standard treatment In parallel, multiple Phase 1b/2 trials are evaluating IBI363 in NSCLC and CRC including the first-line and later line settings, and in additional tumor types. IBI363 has received two Fast Track Designations (FTD) from the U.S. FDA and three Breakthrough Therapy Designations (BTD) from China NMPA so far. In October 2025, Innovent entered into a license and collaboration agreement with Takeda, under which Innovent and Takeda will co-develop IBI363/TAK-928 globally and co-commercialize IBI363/TAK-928 in the U.S., and Takeda will exclusively commercialize IBI363/TAK-928 worldwide outside of the U.S. and greater China. About Innovent Biologics Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 19 products in the market. It has 1 asset under NMPA review, 5 assets in phase 3 or pivotal clinical trials, and 14 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Roche, Takeda, Pfizer, Sanofi, Incyte, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Statement: Innovent does not recommend the use of any unapproved drug (s)/indication (s). Ramucirumab Injection (Cyramza®), Selpercatinib Capsules (Retsevmo®), Pirtobrutinib Tablets (Jaypirca®) and abemaciclib (Verzenios®) are products discovered and developed by Eli Lilly. Forward-looking statement This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions. Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect. References: GLOBOCAN 2024. Huyghe N, et al. Biomarkers of Response and Resistance to Immunotherapy in Microsatellite Stable Colorectal Cancer: Toward a New Personalized Medicine. Cancers (Basel). 2022 Apr 29;14(9):2241. Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Grothey, Axel et al. The Lancet, Volume 381, Issue 9863, 303 – 312. Li J, Qin S, Xu R, et al. Effect of Fruquintinib vs Placebo on Overall Survival in Patients With Previously Treated Metastatic Colorectal Cancer: The FRESCO Randomized Clinical Trial. JAMA. 2018;319(24):2486–2496. doi:10.1001/jama.2018.7855. Prager G et al. Trifluridine-Tipiracil and Bevacizumab in Refractory Metastatic Colorectal Cancer. N Engl J Med. 2023 May 4;388(18):1657-1667. SOURCE Innovent Biologics 21% more press release views with Request a Demo

Phase 3Fast TrackPhase 1License out/inImmunotherapy

05 Aug 2026

·www.pharmaindustrial-india.com

Innovent Doses First Patient in Pivotal IBI363/TAK-928 CRC Study

Innovent Biologics announced that the first patient has been dosed in a pivotal study evaluating IBI363 (Takeda R&D code: TAK-928), a potential first-in-class PD-1/IL-2α-biased bispecific fusion protein, in combination with bevacizumab versus investigator's choice of therapy, in patients with advanced colorectal cancer (CRC) that is refractory or intolerant to standard treatment. This is the third pivotal registrational clinical study initiated for IBI363 and marks a critical step forward for investigational next-generation Immuno-Oncology (IO) therapies in overcoming colorectal cancer—a classic 'immune-cold' tumor. Previously initiated studies of IBI363 include a pivotal phase 2 clinical study (NCT07217301) in China for IO-naïve melanoma (acral and mucosal subtypes). A global, multi-center, phase 3 clinical study (NCT06797297) in IO-resistant squamous Non-Small Cell Lung Cancer (NSCLC) has also been initiated. As part of a license and collaboration agreement, Innovent and Takeda are co-developing IBI363/TAK-928 globally and will co-commercialise IBI363/TAK-928 in the US Takeda will exclusively commercialise IBI363/TAK-928 worldwide outside of the US and greater China. This trial (NCT07722494) is a multicenter, randomised, open-label, phase 3 clinical study designed to evaluate the efficacy and safety of IBI363 in combination with bevacizumab compared with investigator's choice of therapy in patients with advanced colorectal cancer who have failed or are intolerant to standard therapies. A total of 550 patients are planned to be enrolled. The primary endpoint of this study is Overall Survival (OS). This study is being conducted in China where Innovent holds development and commercialisation rights for IBI363/TAK-928. At the 2025 ASCO Annual Meeting, data from a phase 1 clinical study of IBI363 for the treatment of advanced colorectal cancer was presented as an oral presentation. IBI363 in combination with bevacizumab demonstrated encouraging efficacy signals and a manageable safety profile. Among patients treated with IBI363 in combination with bevacizumab (n=73), the overall confirmed Objective Response Rate (cORR) was 15.1 percent, and the Disease Control Rate (DCR) was 61.6 percent. With a median follow-up of 9.9 months, the Progression-Free Survival (PFS) reached 4.7 months. With a median follow-up of 9.4 months, Overall Survival (OS) data remained immature, with only 13 events (17.8 percent) observed. The overall safety profile was clinically manageable, and no new safety signals were observed. The incidence of grade 3 or higher Treatment-Related Adverse Events (TRAEs) in the combination therapy group was 35.6 percent. The most common TRAEs were arthralgia, anemia, rash, and hypothyroidism. Professor Kefeng Ding from the Second Affiliated Hospital of Zhejiang University School of Medicine, the principal investigator of this study, stated, "Colorectal cancer is a common gastrointestinal malignancy that poses a severe threat to human health. Worldwide, it ranks 3 rd in incidence and 2 nd in mortality among all malignant tumors. Approximately, 86 percent of colorectal cancers are in an immune-desert or immune-suppressed state, rendering them unresponsive to traditional Immune Checkpoint Inhibitors (ICIs). For patients with colorectal cancer who have failed standard therapy, treatment options are limited, survival is short, and there remains a huge unmet clinical need. As a PD-1/IL-2α-biased bispecific molecule, IBI363's dual antitumor mechanism—blocking PD-1 while stimulating tumor-specific CD8? T cells (TST cells)—holds the promise of turning 'cold' tumors 'hot'. Early data for IBI363 in combination with bevacizumab in late-line treatment have demonstrated encouraging, breakthrough efficacy along with tolerable safety, showing potential to become a novel immunotherapy for colorectal cancer. I will work closely with other investigators to advance and complete this pivotal clinical study, steadily generating high-quality clinical data to provide colorectal cancer patients with a more effective treatment option." Based on updated long-term follow-up data from the above study, IBI363 in combination with bevacizumab was granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) in May 2026. The proposed indication is for patients with advanced microsatellite stable (MSS) or mismatch repair-proficient (pMMR) colorectal cancer (CRC) who have progressed on ≥ 2 lines of prior standard therapy. The updated study results are planned for presentation at a future international academic conference or publication in an international academic journal. Dr. Hui Zhou, Chief R&D Officer (Oncology), Innovent, stated, "IBI363 represents the evolutionary direction of next-generation immunotherapy—not only potentially improving on the survival benefits of existing IO therapies, but also striving to overcome 'cold' tumors that traditional IO treatments cannot effectively address. Early clinical data demonstrate that IBI363 in combination with bevacizumab achieves significant responses and long-term survival benefits in non-MSI-H/pMMR advanced colorectal cancer, validating its unique mechanism and broad-spectrum potential. Currently, the first batch of core indications for IBI363 has smoothly entered pivotal registration clinical trials. We look forward to offering a new choice for colorectal cancer patients and bringing hope to broader unaddressed areas in immunotherapy."

ImmunotherapyPhase 1Phase 2License out/inPhase 3

02 Jun 2026

·www.biospace.com

ASCO: Pfizer scores in lung, colorectal and prostate cancer but key readouts still to come

iStock, Marut Khobtakhob Pfizer showcased multiple late-breakers at the American Society of Clinical Oncology’s annual conference but its biggest data are expected later this year. Pfizer arrived in Chicago this weekend for the American Society of Clinical Oncology’s annual conference fresh off a $10.5 billion deal with China’s Innovent Biologics, as the company seeks to bolster its oncology pipeline. “It is not a big [ASCO] year from the vantage-point of stock-moving data,” Leerink Partners analyst David Risinger told BioSpace . “The focus is looking forward to the Pfizer readouts ahead.” Risinger noted that the company’s most anticipated updates from an investor standpoint are set for later this year. The New York pharma giant showcased data across more than 40 abstracts at ASCO 2026, plus three late-breakers and several oral presentations. All told, the data ranged from striking, long-term results for approved drugs to previews of what’s coming, including some assets out of China. “We want to go big and make impact,” Johanna Bendell, Pfizer’s chief development officer of oncology, told BioSpace prior to the conference. China Pfizer bets up to $10.5B in 12-candidate cancer collab with China’s Innovent Pfizer continues its dealmaking spree by striking a back-heavy partnership with China’s Innovent Biologics to assemble a pipeline of antibody-based therapies for cancer. May 29, 2026 · 2 min read · Tristan Manalac Read more Wins in lung, colorectal and prostate cancer In its late-breaking abstracts, Pfizer presented new data for drugs already in clinic, cementing them as strong treatment options or providing evidence for their use in earlier-stage disease. The company on Friday shared updated data from its Phase 3 CROWN trial , comparing ALK inhibitor Lobrena to its earlier-generation oral kinase inhibitor Xalkori in patients with previously untreated, ALK-positive advanced non-small cell lung cancer (NSCLC). At seven years, patients taking Lobrena saw an 81% drop in the risk of disease progression or death. These patients had a 55% likelihood of being alive without disease progression, compared to just 3% of those in the control arm. Overall survival (OS) data is not yet available, Bendell said. Pfizer is hoping to see this metric within the next year. “The durability of the benefit is unlike any trial we’ve seen,” Sarah Goldberg, chief of thoracic oncology at Yale Cancer Center, told BioSpace . “The CROWN data have looked good for a long time, but as we get longer-term follow-up, I think it’s more convincing that this should be our choice for first-line treatment.” Meanwhile, Bendell, who previously treated patients with gastrointestinal cancers, is particularly excited about new results from BREAKWATER . The trial evaluates Pfizer’s BRAF inhibitor Braftovi plus Eli Lilly’s Erbitux and the FOLFIRI chemotherapy regimen for previously untreated patients with BRAF V600E-mutant metastatic colorectal cancer, compared to FOLFIRI with or without bevacizumab. FOLFIRI and FOLFOX are common chemo regimens for patients with colorectal cancer, and earlier BREAKWATER data showed strong benefit for Braftovi plus Erbitux and mFOLFOX6. The FDA granted Braftovi full approval in first-line metastatic colorectal cancer in February. In this latest readout from BREAKWATER, the Braftovi/FOLFIRI combo also cut the risk of progression or death, this time by 56%, and PFS nearly doubled to 15.2 months versus 8.3 months in the comparator arm. Risk of death also declined by 44%, according to Pfizer’s Monday press release . “You can choose whichever of the chemotherapy backbones. You’re still going to have a significant impact by bringing Braftovi in for these patients,” Bendell said. Meanwhile, adding Pfizer’s PARP inhibitor Talzenna to the company’s Xtandi resulted in better outcomes for men with HHR-altered metastatic castration-sensitive prostate cancer, according to results from the Phase 3 TALAPRO-3 trial . The combination resulted in a 52% reduction in risk of radiographic progression or death, compared to placebo plus Xtandi. At three years, some 77% of patients on the combination still had radiographic PFS (rPFS), compared to 56% of those in the control arm. The results from TALAPRO-3 could move the combination earlier into the disease course, before castration resistance, Bendell said. “The earlier you move the therapy, the more impact that you can have for patients.” The results could help support the growth of Talzenna going forward, as Xtandi is soon set to face generic competition, Risinger said, adding that those were very important results. A look ahead—and a patent cliff Elsewhere at ASCO, Pfizer unveiled new data from assets designed to be the future of its oncology business. One such drug is the company’s CDK4 inhibitor atirmociclib, the heir apparent to its blockbuster breast cancer drug Ibrance, which loses patent protection next year. Breast cancer Pfizer’s Ibrance Heir Reduces Risk of Death in Phase 2 Breast Cancer Test Pfizer has a lofty goal for the CDK4 inhibitor atirmociclib, the New York pharma’s answer to Ibrance’s loss of patent protection next year. In 2025, Ibrance led Pfizer’s oncology portfolio with $1.04 billion in sales. March 17, 2026 · 1 min read · Annalee Armstrong Read more The Phase 2 FourLight-2 trial evaluated neoadjuvant atirmociclib plus letrozole vs. letrozole alone among 121 patients with HR+/HER2- breast cancer. Based on Ki-67 biomarker data, the proportion of patients taking atirmociclib who achieved complete cell cycle arrest at two weeks was 88.2% compared to 17.9% in the comparator group. Patients on atirmociclib also had more side effects, with nearly 20% experiencing diarrhea. The efficacy was compelling, but the gastrointestinal toxicity is a key question going forward, Risinger said . Pfizer also put up data in the competitive PD-1/VEGF bispecific antibody space, where Summit Therapeutics and its Chinese biopharma partner Akeso made headlines with their candidate ivonescimab. BioNTech and Bristol Myers Squibb also presented solid data for their asset pumitamig. Immuno-oncology ASCO: Summit reached with China lung data but new climb begins to prove global benefit “King Keytruda’s reign continues,” analysts at BMO Capital Markets declared after Chinese data for Summit Therapeutics’ ivonescimab were revealed at the American Society for Clinical Oncology in Chicago. June 1, 2026 · 3 min read · Annalee Armstrong Read more In updated results from a Phase 2 trial of Pfizer’s bispecific PD-1/VEGF antibody SSGJ-707 (PF’4404), the confirmed objective response rate was 75.0% for patients with squamous-cell NSCLC and 63.6% for non-squamous cell NSCLC, with a median PFS of 8.9 months and 12.4 months, respectively. “The data were encouraging, but the jury is still out with respect to which agents will differentiate,” Risinger said. The compound also showed promise in endometrial cancer in a different Phase 2 trial . Among 29 patients with advanced or recurrent endometrial cancer, the confirmed objective response rate was 85.7% at a 5-mg/kg dose and 80.0% at 10 mg/kg. Pfizer paid $1.25 billion upfront to license the bispecific from 3SBio in 2025, and the company has since launched 12 clinical trials in the program and plans to start five more. As for key upcoming data, Risinger pointed to several readouts, including one around the middle of this year for Pfizer’s investigational antibody-drug conjugate (ADC) sigvotatug vedotin (SV) versus docetaxel in second-line NSCLC. Last week, Pfizer amended the primary endpoint to OS only, with the change likely to mildly increase the chance of success, analysts at BMO Capital Markets wrote in a note to investors last Wednesday. PFS will now be a descriptive secondary endpoint, the firm noted. “While such a change reduces our confidence in the robustness of PFS, OS remains the highest importance in NSCLC, making this change rationale for increasing SV’s chances to demonstrate clinically meaningful results,” the analysts wrote. “SV is expected to be a blockbuster for NSCLC,” Risinger said. Also awaited in the second half of 2026 are results from the Phase 3 MEVPRO-1 trial , evaluating the EZH2 inhibitor mevrometostat plus enzalutamide in patients with previously treated metastatic castration-resistant prostate cancer. Plus, this upcoming weekend, Phase 2 data will be presented for Pfizer’s monthly, long-acting injectable GLP-1 that it acquired from Metsera at the 2026 American Diabetes Association ’s Scientific Sessions, as the company builds out its obesity assets. As Risinger said, “there’s a broad pipeline at Pfizer that is needed to offset the patent cliffs ahead.” .responsive-container { display: flex; flex-wrap: wrap; border: 1px solid #ededed; font-family: Helvetica, Arial, Sans-Serif; padding: 20px 20px 10px 20px; } .column-left { flex: 1; max-width: 45%; padding: 20px 20px 10px 20px; } .column-right { flex: 2; padding: 20px 20px 10px 20px; } @media (max-width: 768px) { .column-left, .column-right { max-width: 100%; flex: 100%; padding: 10px 0; } } Subscribe to ClinicaSpace! Clinical trial results, research news, the latest in cancer, cell and gene therapy hbspt.forms.create({ region: "na1", portalId: "4413123", formId: "674f4dc0-7371-4190-86cc-e1afd00b08ea", onFormSubmitted: function($form, data) { window.dataLayer = window.dataLayer || []; window.dataLayer.push({ 'event': 'GTMevent', 'event_name': 'newsletter_sign_up' }); } });

Clinical ResultPhase 3Phase 2Drug ApprovalASCO

100 Deals associated with Bevacizumab biosimilar (Innovent Biologics)

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KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Triple Negative Breast Cancer	Indonesia	PT Etana Biotechnologies Indonesia	14 Jun 2022
Fallopian Tube Carcinoma	China	Innovent Biologics (Suzhou) Co. Ltd.	09 Mar 2022
Ovarian Cancer	China	Innovent Biologics (Suzhou) Co. Ltd.	09 Mar 2022
Primary peritoneal carcinoma	China	Innovent Biologics (Suzhou) Co. Ltd.	09 Mar 2022
Uterine Cervical Cancer	China	Innovent Biologics (Suzhou) Co. Ltd.	09 Mar 2022
Hepatocellular Carcinoma	China	Innovent Biologics (Suzhou) Co. Ltd.	28 Jun 2021
Glioblastoma	China	Innovent Biologics (Suzhou) Co. Ltd.	28 Dec 2020
Colorectal Cancer	China	Innovent Biologics (Suzhou) Co. Ltd.	17 Jun 2020
Non-Small Cell Lung Cancer	China	Innovent Biologics (Suzhou) Co. Ltd.	17 Jun 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Colorectal Adenocarcinoma	Phase 3	China	Innovent Biologics (Suzhou) Co. Ltd.	31 Jul 2026
EGFR positive Non-squamous non-small cell lung cancer	Phase 3	China	Innovent Biologics (Suzhou) Co. Ltd.	01 Jul 2019
Advanced Hepatocellular Carcinoma	Phase 3	China	Innovent Biologics (Suzhou) Co. Ltd.	11 Feb 2019
Advanced Lung Non-Squamous Non-Small Cell Carcinoma	Phase 3	China	Innovent Biologics (Suzhou) Co. Ltd.	28 Nov 2016
Recurrent Lung Non-Squamous Non-Small Cell Carcinoma	Phase 3	China	Innovent Biologics (Suzhou) Co. Ltd.	28 Nov 2016
Metastatic Colorectal Carcinoma	Phase 2	China	Innovent Biologics (Suzhou) Co. Ltd.	01 Jun 2026
Vitelliform Macular Dystrophy	Phase 2	China	Innovent Biologics (Suzhou) Co. Ltd.	01 Jun 2026
Brain metastases	Phase 2	-	Innovent Biologics (Suzhou) Co. Ltd.	01 May 2026
Malignant Solid Neoplasm	Phase 2	-	Innovent Biologics (Suzhou) Co. Ltd.	01 May 2026
Metastatic Cholangiocarcinoma	Phase 2	China	Innovent Biologics (Suzhou) Co. Ltd.	01 Jan 2026

Clinical Result

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Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05617430 (ESMO_ASIA2024) Manual	Phase 2	Advanced Hepatocellular Carcinoma First line	38	mFOLFOX6-HAIC + Sintilimab + IBI305	fseldlbnpy(lmjaelcdvh) = rtsymnxurs igwbwuejls (jptfbcxlfe ) View more	Positive	07 Dec 2024
NCT04735861 (INOVA, Pubmed \| NEWS) Manual	Phase 2	Recurrent Ovarian Clear Cell Adenocarcinoma \| Ovarian clear cell carcinoma Second line	37	sintilimab+bevacizumab	sqelcgnici(zdbdniclme) = oazrvzycac tcbhgyrhqf (laituvfccf, 24.8 - 57.9) View more	Positive	11 Sep 2024
NCT05029973 (ASCO2024)	Phase 2	Unresectable Hepatocellular Carcinoma HBV infection \| HCV \| AFP levels ... View more	106	FOLOFOX-HAIC + Sintilimab + IBI305	delywdsblz(lwzyhqxyva) = tlbzrsldso jiuboeohbl (apnkuwyiqp ) View more	Positive	24 May 2024
NCT03794440 (ORIENT-32, ASCO2023) Manual	Not Applicable	Unresectable Hepatocellular Carcinoma First line	43	Sinilimab+bevacizumab	gylsrbcjks(idnnuglwab) = foudeocdog nvoddkocbm (synztdobmh, NE - NE) View more	Similar	31 May 2023
				Sorafenib	gylsrbcjks(idnnuglwab) = soleetoyie nvoddkocbm (synztdobmh, 11.1 - 21.1) View more
NCT03794440 (ASCO_GI2023) Manual	Phase 3	Unresectable Hepatocellular Carcinoma	586	sintilimab+IBI305	evbcjoyygj(bxoodxczad) = uozimxiyst gznkrpincv (hjtacvqhjq ) View more	Positive	24 Jan 2023
				sorafenib 400 mg	evbcjoyygj(bxoodxczad) = ayledgdvck gznkrpincv (hjtacvqhjq ) View more
NCT03794440 (ORIENT-32, ASCO_GI2023) Manual	Phase 2/3	Unresectable Hepatocellular Carcinoma First line	536	sintilimab 200 mg+IBI305 15 mg/kg	xaynunbvaf(rnyytwnvrt) = ifickzwqpi gjahwwxxgs (hdowngcgtd ) View more	Positive	24 Jan 2023
				sorafenib 400 mg	xaynunbvaf(rnyytwnvrt) = cvwfoyboxj gjahwwxxgs (hdowngcgtd ) View more
NCT03802240 (ORIENT-31, ESMO2022) Manual	Phase 3	EGFR-mutated non-small Cell Lung Cancer EGFR Mutation	476	Sintilimab+IBI305+chemotherapy (Arm A)	mxsujlbxxj(dvqmyswfxs) = oberdgrsxc hkwobnhrva (oeshtgcpuw, 6.6 - 9.3) View more	Positive	11 Sep 2022
				Sintilimab+placebo 2+chemotherapy (Arm B)	mxsujlbxxj(dvqmyswfxs) = nqfaarbqzc hkwobnhrva (oeshtgcpuw, 4.5 - 6.1) View more
NCT04735861 (INOVA, ESMO2022) Manual	Phase 2	Ovarian clear cell carcinoma	23	sintilimab 200 mg +IBI305 15mg/kg	rcfnsqhxwf(fozhakovzk) = hkwrfhiwnm suywfodwgy (ndfzggotwk, 19.1 - 63.9) View more	Positive	10 Sep 2022
NCT05029973 (ASCO2022) Manual	Phase 2	Unresectable Hepatocellular Carcinoma	30	HAIC+sintilimab+IBI305	fcflzjcken(caneziupia) = pznagbwqgo ybysgfdurm (vrnkmtjcrs ) View more	Positive	02 Jun 2022
NCT03794440 (ORIENT-32, Pubmed \| Lancet Oncol) Manual	Phase 2/3	Unresectable Hepatocellular Carcinoma First line	571	Sintilimab+IBI305	wrbturzzur(ekvevmpicd) = fcokylhupp rxekxawbjh (zwghtfepyy ) View more	Positive	01 Jul 2021
				sorafenib	wrbturzzur(ekvevmpicd) = srceoulgay rxekxawbjh (zwghtfepyy ) View more

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