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Latest oncology clinical development updates
Monday, February 09, 2026
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OTW News Highlights this week
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On October 16, 2026, the Food and Drug Administration granted traditional approval to pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) for adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) solid tumors, as determined by an FDA-authorized test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.
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“MonumenTAL-3 demonstrated significant improvements in progression-free survival, overall survival, response rates and depth of response with the combination of talquetamab and daratumumab,” said Ester in ’t Groen, EMEA Therapeutic Area Head, Haematology, Johnson & Johnson. “For patients facing their first relapse, this combination has the potential to provide deep responses and keep their disease under control for longer at a …
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"We are pleased that the 11th indication application for sintilimab has been accepted for review by the NMPA, with the potential to offer a more effective treatment option for patients with advanced melanoma in China," said Dr. Hui Zhou, Chief R&D Officer of Oncology at Innovent. "This acceptance further consolidates the position of sintilimab as a cornerstone therapy in immuno-oncology. …
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“As the first Phase 3 readout from our Rina-S program, the positive topline results from RAINFOL-02 mark a significant milestone for Genmab and strengthen our confidence in Rina-S’s potential for patients with platinum-resistant ovarian cancer. These results advance our ambition to become a leader in gynecologic oncology and reflect our commitment to improving the lives of patients with high unmet …
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“We believe TCEs have a powerful role to play in the future of immunotherapy to treat cancer. This collaboration with Gilead provides an opportunity to generate multiple differentiated candidates aimed at difficult-to-address solid tumors and to expand the potential impact of our science, while also advancing our own clinical oncology portfolio,” said Marianne De Backer, President and Chief Executive Officer …
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“Activating UC Davis as a clinical site is a meaningful operational milestone for CERo and for the CERTAIN-T study,” said Kent Cunningham, Chief Executive Officer of SRX Global. “Bringing manufacturing and patient enrollment together at a single, highly regarded academic institution, streamlines logistics while strengthening the overall clinical trial footprint. This progress reinforces our conviction in CERo’s differentiated approach to …
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Akeso, Inc. and its partner Summit Therapeutics Inc. jointly announced an international multicenter Phase II clinical study (SMT112-216 / AK112-216 / NCT07877194). Built on Akeso’s first-in-class immuno-oncology (IO) cornerstone therapy ivonescimab (PD-1/VEGF bispecific antibody), the study will assess the efficacy and safety of multiple treatment regimens, including the combination of ivonescimab with Akeso’s first-in-class bispecific antibody cadonilimab (PD-1/CTLA-4 bispecific antibody), …
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“This collaboration supports our broader development strategy for petosemtamab as we explore its potential across treatment settings and in novel combinations,” said Judith Klimovsky, M.D., Executive Vice President and Chief Development Officer, Genmab. “Partnering with Incyte enables us to evaluate this investigational combination in patients with KRAS G12D-mutated metastatic colorectal cancer, reflecting our commitment to research collaborations aimed at expanding …
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“We are delighted to see the global clinical development of ivonescimab further expand into the field of biliary tract cancer. Against the background of the positive OS results from the Phase III HARMONi-GI1 study of ivonescimab plus chemotherapy versus durvalumab plus chemotherapy, the advancement of the Phase III EA2251 study by a leading cooperative oncology group in the United States …
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Author
Managing Editors
Social Media Managers
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Disclaimer: The OTW team takes care to share authentic information. In case of any discrepancies please write to newsletter@onco-this-week.com. Our website is an aggregator for open-source oncology news. The information on our website is provided without any representations or warranties. OTW is a part of RLS Consultants, which is a global consulting and training firm focusing exclusively on the healthcare and life sciences industries. RLS is a leading provider of opportunity assessment services, utilizing its comprehensive expertise in strategic market research, forecasting, and modeling, as well as pricing and market access to facilitate commercial assessments. RLS does not have any influence on any news reported on OTW. The views and opinions expressed in this article are those of the authors and do not necessarily reflect the official policy or position of RLS. The content on our website is intended strictly for news and information purposes only and should not be treated as a substitute for medical advice, diagnosis, or treatment. News shared on OTW should not be utilized in real-world analytic products as they are based only on limited and dated open-source information.
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