CLINICAL AND REGULATORY
Enhertu recommended for approval in EU for patients with HER2+ metastatic breast cancer
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been recommended by CHMP for approval in EU as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens. Enhertu is a specifically engineered HER2-directed ADC being jointly developed and commercialized by AstraZeneca and Daiichi Sankyo. Recommendation is based on DESTINY-Breast03 trial results showing AstraZeneca and Daiichi Sankyo’s Enhertu reduced the risk of disease progression or death by 72% vs. trastuzumab emtansine (T-DM1).
Everest wins first China approval with Trodelvy in breast cancer
Everest Medicines announced that China’s NMPA has approved Trodelvy (sacituzumab govitecan) for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease. This is the first drug that Everest has obtained NDA approval to launch in China.
Trodelvy improved PFS by 34% in heavily pretreated HR+/HER2- metastatic BRCA patients
Gilead announced positive results from the primary analysis of the Phase 3 TROPiCS-02 study of Trodelvy (sacituzumab govitecan-hziy) versus physicians’ choice of chemotherapy in heavily pre-treated HR+/HER2- metastatic breast cancer patients who received prior endocrine therapy, CDK4/6 inhibitors and two to four lines of chemotherapy. The study met its primary endpoint of PFS with a statistically significant and clinically meaningful 34% reduction in the risk of disease progression or death (median PFS 5.5 vs. 4 months). The first interim analysis of the key secondary endpoint of OS demonstrated a trend in improvement. These data are immature, and patients will be followed for subsequent OS analysis.
ADCT announced results from pivotal Phase 2 of Cami in Hodgkin lymphoma
ADC Therapeutics announced results from the ongoing pivotal Phase 2 clinical trial of camidanlumab tesirine (Cami) in relapsed or refractory Hodgkin lymphoma. An ORR of 70.1% and a CR rate of 33.3% was observed with a median DOR of 13.7 months for all responders in r/r Hodgkin lymphoma patients who were refractory or had relapsed after a median of 6 prior treatments, including brentuximab vedotin and a PD-1 blockade. The safety profile of Cami was substantially consistent with previously reported interim findings. ADCT is now preparing for potential submission of a BLA to the FDA.
DEALS AND FINANCING
Merck rumored to be interested in taking over Seagen
Seagen added over $4 billion in value after the Wall Street Journal published a report that Merck & Co. was exploring a possible acquisition of the biotech. The rumors sent Seagen shares up by 15%, giving Seagen a market cap of about $31 billion. The acquisition at that valuation would make it the largest biotech takeout since 2020’s takeout of Alexion Pharma for $39 billion.
ImmunoGen announced collaboration with Oxford BioTherapeutics to develop novel ADCs
Immunogen announced a multi-year collaboration to research novel ADCs with Oxford Bio, a clinical stage oncology company with a pipeline of immuno-oncology and ADC-based therapies, utilizing ImmunoGen's proprietary linker-payload technology directed to novel targets identified via OBT's proprietary OGAP discovery platform. After antibodies generated by Oxford Bio have been coupled with ImmunoGen's proprietary linker-payload technology, each company will have the opportunity to select one or more development programs to further develop on its own.
DAC Bio announces a collaboration with Janssen for the development of novel ADCs
Hangzhou DAC Biotechnology announced a collaboration and license agreement with Janssen. DAC Biotech will apply its innovative and proprietary ADC platform to Janssen’s proprietary antibodies with the aim to develop novel ADC products against up to five targets. DAC Biotech has also received an equity investment from Johnson & Johnson Innovation. DAC Biotech will fully leverage its intellectual properties and proprietary ADC platform, while Janssen will provide its expertise in proprietary antibodies, clinical development, and global commercialization. DAC is eligible to receive an upfront payment, cost reimbursement and milestone payments, plus royalties on worldwide sales for each selected product.