This week, both Merck MRK and J&J JNJ announced plans to acquire cancer biotechs making oncology therapies with novel mechanisms of action. AbbVie ABBV announced positive data from a mid-stage study on a skin disease candidate. Pfizer PFE provided some regulatory updates.

Recap of the Week’s Most Important Stories

J&J to Acquire Ambrx Biopharma: J&J announced a definitive agreement to acquire Ambrx Biopharma for a total equity value of approximately $2.0 billion. The acquisition will strengthen J&J’s oncology pipeline by adding the latter’s lead pipeline candidate, ARX517, a prostate-specific membrane antigen targeting antibody drug conjugate (ADC), being developed for metastatic castration-resistant prostate cancer (mCRPC). Ambrx is developing next-generation ADCs, leveraging its proprietary synthetic biology technology that effectively kills cancer cells and limits toxicities associated with chemotherapy treatment.

Merck to Buy Harpoon Therapeutics: Merk announced plans to acquire Harpoon Therapeutics for $23.00 in cash, which amounts to an approximate total equity value of $680 million. The acquisition will strengthen Merck’s oncology pipeline by adding Harpoon’s lead pipeline candidate, HPN328, a T cell engager. HPN328 is currently being evaluated in a phase I/II study in certain patients with small cell lung cancer (SCLC) and other neuroendocrine tumor types. In October, Harpoon Therapeutics presented positive interim data from the phase I/II study.

FDA Grants Priority Review Status to Pfizer’s Tivdak sBLA: Pfizer announced that the FDA has accepted and granted priority review status to a supplemental biologics license application (sBLA), seeking to convert the accelerated approval of Tivdak (tisotumab vedotin-tftv) to a full approval. The sBLA is based on positive data from the global phase III innovaTV 301 study, which demonstrated the overall survival benefit of Tivdak over chemotherapy. Tivdak was granted accelerated approval by the FDA for previously treated recurrent or metastatic cervical cancer in September 2021. Tivdak was added to Pfizer’s portfolio following the acquisition of Seagen, which was closed in December 2023.

Pfizer also announced that the European Commission has granted approval to a combination of its cancer drugs, Talzenna plus Xtandi (standard of care), for treating mCRPC. With the approval, Talzenna became the first and only PARP inhibitor approved in combination with Xtandi, which is the standard of care for mCRPC, in the European Union. The approval was based on data from the phase III TALAPRO-2 study. Talzenna plus Xtandi was approved in the United States for HRR gene-mutated mCRPC based on data from the TALAPRO-2 study in June 2023.