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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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"VENCLYXTO-based combination regimens have demonstrated a favorable efficacy and safety profile in the first-line setting for chronic lymphocytic leukemia," said Svetlana Kobina, MD, PhD, vice president, global medical affairs, oncology, AbbVie. "The inclusion of additional fixed-duration, chemotherapy-free, oral VENCLYXTO combinations in the label helps address the evolving needs of patients and healthcare providers, as they consider disease management options with …
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“These achievements represent a defining moment for Ernexa Therapeutics,” said Sanjeev Luther, CEO of Ernexa Therapeutics. “Completing process development and advancing into GMP manufacturing are critical steps toward IND clearance and the launch of our first-in-human clinical study for ERNA-101. We are executing against our development strategy with urgency and discipline and remain firmly on track for our planned IND …
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"We are grateful to the FDA leadership for their willingness to engage in a collaborative dialogue towards finding a meaningful path forward for RP1," said Sushil Patel, Ph.D., Chief Executive Officer of Replimune. "We are encouraged by the agency's commitment to supporting patients and U.S. innovation and look forward to working closely with the FDA to bring this important therapy …
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“The results from the Phase 2b trial underscore the biological complexity of lower-risk myelodysplastic syndromes and the challenges of identifying patients most likely to benefit. On behalf of the entire Agios team, I want to extend our sincere gratitude to the patients, caregivers, investigators, and broader community who made this research possible,” said Sarah Gheuens, M.D., Ph.D., Chief Medical Officer …
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Shanghai Junshi Biosciences announced that a randomized, double-blind, placebo-controlled, multi-center phase III clinical study (“NEOTORCH”, NCT04158440) of the company’s product toripalimab in combination with platinum-containing doublet chemotherapy as perioperative treatment for resectable stage II-III non-small cell lung cancer (“NSCLC”) patients has finished its final analysis. The primary endpoints of event-free survival (“EFS”) and major pathological response (“MPR”) rate in the …
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“Dosing the first patient in the Phase 2 POLKA study marks a significant step in realizing the potential of ART6043 and advancing a new class of targeted therapies for patients with gBRCAm HER2-negative breast cancer,” said Ian Smith, Chief Medical Officer of Artios. “Patients continue to face limited effective treatment options, underscoring the need for new therapies beyond current standards …
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Henlius announced that the first patient has been dosed in China in a randomized, double-blind, multicentre, parallel-controlled Phase 2/3 clinical trial evaluating its self-developed recombinant anti-EGFR mAb pimurutamab (HLX07) in combination with the anti-PD-1 mAb serplulimab and chemotherapy for the first-line treatment of advanced squamous non-small cell lung cancer (sqNSCLC). This milestone marks the official initiation of the study’s clinical …
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Patrick Mehlen, PhD, Chief Executive Officer of NETRIS Pharma, said: « We are delighted to receive this Horizon Europe grant, which is a further validation of both our scientific approach and our development strategy in head and neck cancer. NP137 is the only clinical-stage anti-netrin1 therapy, and HNSCC is a key indications given the resistance to current treatment. Conducting this …
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Dr. Lone Ottesen, Chief Medical Officer of Adcendo, said: “We are excited to work together with MSD on this new clinical trial combining ADCE-T02, our novel tissue factor-targeting ADC with pembrolizumab. Through this collaboration of potentially complementary mechanisms, we may be able to positively impact clinical outcomes for patients battling cancers where tissue factor is known to be overexpressed, such …
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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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