Onco-Summaries: Daily Oncology Updates at a Glance

23/09/2025

Kelun Biotech's NDA for A400/EP0031 in RET +ve NSCLC was accepted by China's NMPA (Ref)

China's NMPA has accepted Sichuan Kelun-Biotech's NDA for A400/EP0031 (RET kinase inhibitor) for the treatment of adult patients with RET-fusion positive locally advanced, or metastatic NSCLC

• The acceptance for review was based on the positive results from the two pivotal Ph2 cohorts of the KL400-I/II-01 study for both 1L and 2L+ advanced RET-fusion positive NSCLC

  
  

• To note, in Mar'21, Ellipses Pharma Limited received an exclusive license to develop, manufacture and commercialize EP0031 outside Greater China and certain Asian countries

In the Ph3 EXCALIBER-RRMM trial, iberdomide + SOC elicited a significant improvement in MRD negativity rates in R/R MM (Ref)

BMS' Phase 3 EXCALIBER-RRMM trial of iberdomide (cereblon E3 ligase modulator) + daratumumab + dexamethasone demonstrated a statistically significant improvement in MRD negativity rates vs control arm in patients with relapsed or refractory multiple myeloma.

• In accordance with the trial design and based on the recommendation from the Data Monitoring Committee, the trial will continue without changes to evaluate the other dual-primary endpoint of PFS, and the key secondary endpoint of OS and safety

• Anne Kerber, SVP, Head of Development, Hematology, Oncology and Cell Therapy: “This result builds on our significant experience in both targeted protein degradation and developing new treatment options for patients living with multiple myeloma. Iberdomide represents the first of a novel class of medicines, called CELMoDs, which has the potential to create a new foundation for multiple myeloma treatment that may be combined with other therapies.”

TegMine Therapeutics and Boehringer Ingelheim enter into a collaboration to advance novel 2-Factor antibody system for cancer (Ref)

TegMine Therapeutics and Boehringer Ingelheim entered a strategic research and development collaboration to leverage TegMine’s proprietary 2-Factor Antibody System to develop more selective and better-tolerated ADC therapeutics.

• Under the terms of the agreement, TegMine will receive an upfront payment and research funding per target as well as a target option fee for each selected additional target

• The company is also eligible to receive preclinical, clinical, regulatory, and commercial milestones, along with royalties on net sales for any potential products developed under the collaboration

• Exact financial terms are undisclosed

• Boehringer Ingelheim has global development and commercial rights for each target generated during the collaboration