Share this emailCopy the public link or share it on your favorite channel.

Latest oncology clinical development updates

Monday, February 09, 2026

OTW News Highlights this week

European Commission approves TECVAYLI (teclistamab) plus daratumumab for relapsed/refractory multiple myeloma

“This new indication for teclistamab plus daratumumab brings forward a new standard of care for patients in Europe living with relapsed or refractory multiple myeloma,” said Ester in ‘t Groen, EMEA Therapeutic Area Head, Haematology, Johnson & Johnson. “By combining the complementary mechanisms of teclistamab, a BCMAxCD3 bispecific antibody, with daratumumab, a well-established standard of care that helps modulate the …

FDA written feedback provides alignment on a potential pivotal Part B expansion of the ongoing REO 033 study

“We are thrilled with the response provided by the FDA and believe this feedback could support a highly efficient path to potentially transition REO 033 from its ongoing randomized Part A directly into a pivotal Part B,” said Jared Kelly, Chief Executive Officer of Oncolytics. “Importantly, the feedback provides alignment around the potential use of response rate to support an …

NMPA CDE clears IND application for AK157D1 for Ph 1 study in solid tumor patients

Akeso, Inc. today announced that its investigational next-generation B7-H3-targeting antibody-drug conjugate (ADC), AK157D1, has received clinical trial clearance from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). The clearance allows initiation of a Phase I study in patients with advanced malignant solid tumors. Development of AK157D1 in combination with Akeso's proprietary bispecific antibodies ivonescimab and …

Ph 3 INTerpath-001 Trial of Intismeran Autogene + KEYTRUDA Met RFS and DMFS Endpoints in Patients With Completely Resected Stage IIB-IV Melanoma

“By intervening earlier in the course of disease, when many cancers are considered most treatable, the goal of adjuvant therapy given after surgery is to increase the possibility of cure for more patients,” said Dr. Dean Y. Li, president, Merck Research Laboratories. “These first Phase 3 findings for intismeran in combination with KEYTRUDA as adjuvant therapy reinforce the promise of …

FDA clears IND application for C-CAR039 (Prizloncabtagene Autoleucel or Prizlon-cel) for the treatment of R/R LBCL

“We are pleased to welcome C-CAR039 back to our hematology malignancy portfolio,” said Tony (Bizuo) Liu, Chairman and Chief Executive Officer of AbelZeta. “Clinical trial results to date have demonstrated the favorable safety and encouraging efficacy of C-CAR039 in r/r LBCL patients. We believe that it has potential to help patients who have been treated and relapsed with commercially approved …

SUPRAME topline data disclosure for the final PFS analysis expected in H1 2027, followed by BLA submission in 2027

“The Phase 3 SUPRAME trial continues to enroll patients on schedule across sites in North America and Europe. In parallel, the data from the Phase 1b anzu-cel study continue to mature. We are now observing that aggregate progression and death events in the SUPRAME trial are occurring more slowly than originally modeled. Based on these results and FDA feedback, we …

Enrollment opens in Ph 1 Clinical Trial Evaluating Treatment of Malignant Brain Tumors with APTN-101

“Opening enrollment in the Phase 1 trial is an important milestone in the clinical development of APTN-101, a potential best-in-class therapy for the treatment of glioblastoma,” said Michael J. Roberts, Ph.D., President and CEO of Adaptin Bio. “In preclinical studies, APTN-101 demonstrated impressive efficacy targeting glioma cells with precision, eliminating some malignant glioma tumors across multiple aggressive disease models. Our …

AbelZeta Regains Global Rights of C-CAR039 (Prizlon-cel) and Receives FDA Clearance of IND Application in LBCL

“We are pleased to welcome C-CAR039 back to our hematology malignancy portfolio,” said Tony (Bizuo) Liu, Chairman and Chief Executive Officer of AbelZeta. “Clinical trial results to date have demonstrated the favorable safety and encouraging efficacy of C-CAR039 in r/r LBCL patients. We believe that it has potential to help patients who have been treated and relapsed with commercially approved …

Akiram Therapeutics and ITM Sign Lutetium-177 Supply Agreement to Support Development of AKIR001 for the Treatment of Solid Tumors

“We are pleased to partner with ITM, a leading global producer and supplier of n.c.a. Lu-177, as we continue advancing AKIR001 through clinical development,” said Marika Nestor, chief executive officer of Akiram Therapeutics. “This agreement helps secure an important component for the continued development of AKIR001 and marks a significant step in advancing the program designed to address a primary …

Editor's Desk

Author

Managing Editors

Social Media Managers

linkedin 
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.