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Latest oncology clinical development updates

Monday, February 09, 2026

OTW News Highlights this week

Jaypirca (pirtobrutinib) receives expanded indication from US FDA for 1L CLL/SLL patients

"This additional approval for Jaypirca, based on BRUIN CLL-313, marks a significant step forward, expanding its potential to reach more patients who may benefit – this time as an initial treatment for certain previously untreated patients with CLL or SLL," said Jacob Van Naarden, executive vice president and president of Lilly Oncology. "This milestone underscores Jaypirca's versatility in the CLL …

US NDA for ORPATHYS® plus TAGRISSO® in MET-Driven EGFR-Mutated Lung Cancer submitted

Mr Johnny Cheng, Acting Chief Executive Officer and Chief Financial Officer of HUTCHMED, said: “This filing is an important step toward potentially bringing ORPATHYS® plus TAGRISSO® to patients in the US, after its approval in China based on the SACHI Phase III trial. The success of the global SAFFRON Phase III trial reflects the long-standing collaboration between HUTCHMED and AstraZeneca …

FDA Fast Track Designation for Plinabulin in Post-ICI Non-Squamous NSCLC

“We believe the FDA Fast Track designation, an FDA-aligned global Phase 3 strategy, and funding to support China-generated clinical data would meaningfully strengthen our ability to advance Plinabulin and DUBLIN-4 toward the trial’s next major clinical milestone—the prespecified interim analysis at 221 PFS events,” said Min Qiu, CEO of BeyondSpring. “Fast Track designation underscores the significant unmet medical need for …

Results from VIRAGE Ph 2b Trial of VCN-01 in Metastatic Pancreatic Cancer Published in Nature Medicine

“We are proud to see the peer-reviewed results from the VIRAGE trial published in Nature Medicine and made available to the entire scientific community,” said Manel Cascalló, PhD, General Director of Theriva Biologics S.L. and co-author of the article. “As elaborated in the publication, improved overall survival, progression free survival, and duration of response were observed in metastatic pancreatic cancer …

Positive topline results from Ph 3 AZTOUND trial of oral azacitidine and cedazuridine (ASTX030) in MDS and CMML patients announced 

“The positive topline results of the Phase 3 AZTOUND trial support the potential of an all-oral regimen of azacitidine and cedazuridine to meet the treatment needs of patients with MDS and CMML without the time and treatment burden associated with parenteral therapies,” said Harold Keer, MD, PhD, Chief Medical Officer, Taiho Oncology. “We look forward to pursuing regulatory approval of …

First patient dosed with LNK001 in Ph 1 study in patients with advanced or metastatic clear cell RCC

“From the beginning, our vision has been to translate this breakthrough science into therapies that can make a profound difference for people impacted by cancer,” said co-founder Robbie Majzner, M.D., of the Dana-Farber Cancer Institute and Harvard Medical School. “Bringing in leaders with the experience, commitment and passion to advance our technology and execute at scale gives me tremendous confidence …

Second Patient treated in the Fifth Cohort of Ovarian Cancer FSHR-targeted CAR-T Clinical Trial

Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, stated, "Ovarian cancer remains one of the deadliest cancers affecting women, and patients with recurrent disease face limited treatment options and poor outcomes. While this Phase 1 study is primarily designed to evaluate safety, we are highly encouraged that multiple patients have surpassed one year of survival following treatment, with one …

Nurix Therapeutics Announces Second Research Term Extension for Oncology Program Under Collaboration with Gilead Sciences

“Gilead’s decision to extend the research term for this program reflects our longstanding commitment to productive collaborations, the outstanding dedication of our research teams, and the potential of Nurix’s targeted protein degradation platform to generate novel medicines against therapeutically important targets,” said Gwenn M. Hansen, Ph.D., chief scientific officer of Nurix. “Our collaboration has already advanced GS-6791, an oral IRAK4 …

United Immunity Announces Master Clinical Supply Agreement with Roche to Evaluate UI-102 + Anti–PD-L1 Therapy in Advanced Solid Tumors

"We are pleased to collaborate with Roche to advance the development of UI-102 for patients with hard-to-treat cancers," said Masato Kishida, Chief Executive Officer of United Immunity. "In preclinical studies, UI-102 demonstrated enhanced anti-tumor activity in combination with immune checkpoint inhibitors compared with checkpoint inhibitor monotherapy in tumor models that were otherwise resistant to checkpoint blockade. We believe these findings …

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