Pfizer announced positive OS in Phase 3 of Adcetris in patients with relapsed or refractory DLBCL

CLINICAL AND REGULATORY

Pfizer announced positive OS in Phase 3 of Adcetris in patients with relapsed or refractory DLBCL

Positive outcomes were also observed in key secondary endpoints, including PFS and ORR. The safety and tolerability of Adcetris in the ECHELON-3 trial were consistent with what has been previously presented for patients with relapsed/refractory DLBCL treated with Adcetris in clinical trials. Full data will be submitted for presentation at an upcoming medical meeting. Pfizer will discuss regulatory submission with FDA, potentially leading to an eighth indication for Adcetris.

GSK announced positive results from DREAMM-8 Phase 3 for Blenrep in multiple myeloma

GSK announced positive headline results from an interim analysis of the DREAMM-8 Phase 3 head-to-head trial evaluating Blenrep (belantamab mafodotin), in combination with pomalidomide plus dexamethasone (PomDex), versus a standard of care, bortezomib plus PomDex, as a second line and later treatment for relapsed or refractory multiple myeloma. The trial met its primary endpoint of PFS at a pre-specified interim analysis and was unblinded early based on the recommendation by an Independent Data Monitoring Committee. The Blenrep combination significantly extended the time to disease progression or death versus the standard of care combination. A positive OS trend favouring the Blenrep combination was also observed at the time of this analysis. The trial continues to follow up for OS. The safety and tolerability of the belantamab mafodotin regimen were broadly consistent with the known safety profile of the individual agents.

Datopotamab deruxtecan significantly improved PFS in two types of cancer

EMA has validated two MAAs for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan (Dato-DXd) in two types of cancer. One MAA is for the treatment of adult patients with locally advanced or metastatic nonsquamous NSCLC who require systemic therapy following prior treatment. The other MAA is for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have progressed on and are not suitable for endocrine therapy and received at least one additional systemic therapy. The validations confirm the completion of the applications and commence the scientific review process by the EMA’s Committee for Medicinal Products for Human Use. The applications are based on data from the pivotal TROPION-Lung01 and TROPION-Breast01 Phase III trials presented during two Presidential Symposia at the 2023 ESMO Congress. Datopotamab deruxtecan is a specifically engineered TROP2-directed DXd ADC discovered by Daiichi Sankyo and being jointly developed by AstraZeneca and Daiichi Sankyo.

DEALS AND FINANCING

Akari and Peak Bio merge as equals creating pipeline that features a novel ADC toolkit

Akari Therapeutics and Peak Bio announced a definitive agreement to merge as equals in an all-stock transaction. The combined entity will operate as Akari Therapeutics, which is expected to continue to be listed and trade on Nasdaq as AKTX. The merged pipeline features a robust ADC toolkit with novel payload and linker technologies. By combining chemotherapy with immunotherapy strategies, the merged company aims to develop cutting-edge solutions for cancer patients. In addition, the program includes a novel pre-clinical ADC candidate targeting TROP-2. Peak stockholders will receive a number of Akari ordinary shares for each share of Peak stock they own, as determined on the basis of the exchange ratio described in the agreement.

Tubulis closed €60 Series B financing to accelerate ins ADC pipeline

Tubulis announced the successful completion of a €60 million Series B financing led by Andera Partners with participation from new investors Evotec and Fund+. All existing investors also participated in the round, including Bayern Kapital, BioMed, Coparion, High-Tech Gründerfonds, Occident and Seventure. The new capital will be used to advance Tubulis’ proprietary pipeline of uniquely assembled ADCs, towards clinical evaluation as well as introduce programs addressing a range of solid tumor indications. The proceeds will enable the company to deliver the true therapeutic potential of ADCs through further innovation of novel payload classes and identification of new cancer targets.