Merck withdrawn BLA for patritumab dx in NSCLC based on Phase 3 modest PFS benefit

CLINICAL AND REGULATORY

Disitamab vedotin gained approval in China for HER2-positive advanced breast cancer

RemeGen announced that disitamab vedotin, a novel HER2-targeted ADC, has been granted approval by the Center for Drug Evaluation (CDE) of China’s NMPA for its third indication of HER2-positive advanced breast cancer with liver metastasis previously treated with trastuzumab or its biosimilar and taxanes. In the pivotal Phase 3 study, disitamab vedotin demonstrated significant improvements in PFS. The median PFS of the DV group doubled that of the standard-of-care group (9.9 months vs. 4.9 months, HR:0.56, P=0.0143). The compound has been approved by NMPA before for HER2-overexpressing locally advanced or metastatic gastric carcinoma previously treated with at least two lines of systemic chemotherapies and HER2-overexpressing locally advanced or metastatic urothelium carcinoma previously treated with platinum-based chemotherapies.

CHMP recommends GSK’s Blenrep approval for multiple myeloma treatment

GSK announced the EMA’s CHMP has recommended the approval of Blenrep for the treatment of adults with relapsed or refractory multiple myeloma in combination with bortezomib plus dexamethasone (BVd) in patients who have received at least one prior therapy, and in combination with pomalidomide plus dexamethasone (BPd) in patients who have received at least one prior therapy including lenalidomide. An approval decision by the European Commission is expected in the third quarter of 2025. The CHMP opinion follows the approval of Blenrep combinations by the UK Medicines and Healthcare products Regulatory Agency (MHRA) in April and Japan’s Ministry of Health, Labour and Welfare earlier this month. Superior efficacy results shown by Blenrep combinations in the pivotal DREAMM-7 and DREAMM-8 phase 3 trials in relapsed or refractory multiple myeloma support the CHMP opinion. These include statistically significant and clinically meaningful PFS results for Blenrep combinations versus standards of care in both trials and OS versus a daratumumab-based triplet in DREAMM-7.

CytomX announced positive Phase 1 data of EpCAM ADC in patients with colorectal cancer

CytomX Therapeutics announced positive interim Phase 1 data for its EpCAM Probody ADC candidate, CX-2051, in advanced, late-line CRC. The data are as of April 7th 2025 data cutoff from the ongoing CTMX-2051-101 Phase 1 study. As of the data cutoff, 18 patients were efficacy-evaluable at the expansion doses of 7.2 mg/kg, 8.6 mg/kg, and 10 mg/kg Q3W. 28% of patients (5/18) achieved confirmed partial responses. ORR for currently approved therapies in third line or later CRC are in the low to mid-single digit percentages. At the 10 mg/kg dose, 3 of 7 evaluable patients (43%) achieved confirmed partial responses. The Disease Control Rate was 94% across the three dose groups (17/18).  Median progression free survival was 5.8 months as of the data cutoff. 10 of 18 patients remained on study treatment as of the data of cutoff.  CX-2051 was generally well-tolerated with manageable adverse events, with no observed dose limiting toxicities. Most treatment related adverse events (TRAEs) were Grade 1 or Grade 2 in severity.

Merck withdrawn BLA for patritumab deruxtecan in NSCLC based on Phase 3 modest PFS benefit

The BLA seeking accelerated approval in the US for Daiichi Sankyo and Merck & Co.’s patritumab deruxtecan (HER3-DXd), based on the HERTHENA-Lung01 Phase 2 trial for the treatment of adult patients with locally advanced or metastatic EGFR-mutated NSCLC previously treated with two or more systemic therapies, has been voluntarily withdrawn. The decision to withdraw the BLA is based on topline overall survival (OS) results from the confirmatory HERTHENA-Lung02 Phase 3 trial where OS did not meet statistical significance, as well as discussions with the U.S. Food and Drug Administration. The decision is unrelated to the Complete Response Letter that was received in June 2024 and outlined findings pertaining to an inspection of a third-party manufacturing facility.

Mersana announced strategic restructuring and reprioritization plan focused on advancing Emi-Le

Mersana announced the implementation of a strategic restructuring and reprioritization plan aimed at extending the company’s cash runway and furthering the development of emiltatug ledadotin (Emi-Le), the company’s B7-H4-directed Dolasynthen ADC. Mersana’s strategic plan will reduce the company’s workforce by approximately 55% across functions. The workforce reduction is expected to be substantially complete by the end of the third quarter of 2025. The company will also reduce its research activities and eliminate its internal pipeline development efforts. In the near term, Mersana will focus Emi-Le development efforts on breast cancer to enable the generation of additional safety, tolerability and clinical activity data. Mersana plans to continue supporting its Phase 1 dose escalation work for XMT-2056 and its ongoing collaborations.