Onco-Summaries: Daily Oncology Updates at a Glance

04/08/2025

Alphamab's IND application for JSKN022 was accepted by China's CDE (Ref)

Alphamab Oncology's IND application for JSKN022 (PD-L1 x integrin αvβ6 bispecific antibody-drug conjugate) has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA).

• The company plans to initiate a first-in-human trial of JSKN022 for the treatment of advanced malignant solid tumors

  
  

• The Ph1 trial will evaluate the safety, tolerability, PK/PD and antitumor activity of JSKN022 in patients with advanced malignant solid tumors who have failed standard therapies, and determine the MTD and/or RP2D

BMS' sBLA for Breyanzi has been accepted for Priority Review by the US FDA for R/R MZL (Ref)

The US FDA accepted BMS' sBLA for lisocabtagene maraleucel (Breyanzi; CD19-directed CAR T cell therapy) as a potential treatment for adult patients with relapsed or refractory marginal zone lymphoma who have received at least two prior lines of systemic therapy.

• The application has received a Priority Review and assigned a PDUFA goal date of Dec 05, 2025

  
  

• The filings was done based on results from the primary analysis of the MZL cohort in Ph2 TRANSCEND FL trial

  
  

• Rosanna Ricafort, Vice President, Senior Global Program Lead for Hematology and Cell Therapy, Bristol Myers Squibb: “While initial therapy for MZL can be effective, multiple relapses over the course of several years are common, leaving patients in need of a new treatment option that can provide high, lasting response rates. This FDA acceptance brings us one step closer to potentially standardizing CAR T cell therapy as a treatment option for MZL, while building on our commitment to bring this personalized therapy to as many eligible patients as possible.”

Akeso received approval to initiate the global Phase II COMPASSION-36 trial of cadonilimab + lenvatinib for Hepatocellular Carcinoma (Ref)

China's NMPA and the US FDA have approved the initiation of Akeso's global, multi-center, randomized Phase II COMPASSION-36/AK104-225 registrational trial of cadonilimab (PD-1 x CTLA-4 bispecific antibody) + lenvatinib (multi-TKI) vs lenvatinib alone for the treatment of advanced hepatocellular carcinoma in patients previously treated with atezolizumab and bevacizumab.

• Dr. Yu Xia, Founder, Chairwoman, President, and CEO, Akeso: "We are excited to initiate cadonilimab's first international multicenter registrational trial, a pivotal step in addressing the global challenge of cancer immunotherapy resistance. This study represents a key milestone in Akeso's global strategy to address the substantial clinical unmet needs in oncology. Akeso is advancing the clinical development of its innovative pipeline, including ivonescimab, cadonilimab, ligufalimab (CD47), and AK146D1 (Trop2/Nectin4 bispecific ADC) through both in-house initiatives and strategic global collaborations. Our goal is to provide accessible and impactful survival benefits to patients worldwide, and to position Akeso at the forefront of oncology innovation.”