FDA granted Priority Review to Enhertu for treatment of HER2-low breast cancer patients

CLINICAL AND REGULATORY

Enhertu gets 4Q22 PDUFA in HER2-low breast cancer

The Phase 3 results, presented at ASCO, showed that the HER-2 directed ADC doubled PFS to 10.1 months from 5.4 months compared with standard of care. AstraZeneca said that about half of breast cancer patients have low HER2 expression. The application is being evaluated under FDA’s Real-Time Oncology Review initiative and Project Orbis.

Seagen, Astellas on track for Padcev label expansion with Phase 1b/2 data

Seagen and Astellas reported that Padcev enfortumab vedotin-ejfv plus Keytruda led to a 64.5% ORR as first-line treatment for cisplatin-ineligible, locally advanced or metastatic urothelial cancer among the 76 patients treated with the combination in Cohort K of the Phase 1b/2 EV-103 study. The response rate dipped from the 73% reported from the 45 patients treated with the combination in Cohort A, but still represents an improvement over either therapy alone, and over standard of care gemcitabine and carboplatin. Keytruda led to an ORR of 29% in 370 cisplatin-ineligible patients in the KEYNOTE-052 study, and the ORR of Padcev monotherapy ranged from about 40% to 50% in pretreated patients. The chemotherapy standard of care leads to responses in about one third of patients. Cohort K was also evaluating Padcev alone in 73 patients, but the partners didn’t report monotherapy data. The top-line readout also leaves unanswered questions about duration of treatment and durability. The number of treatment cycles needed to achieve efficacy may be critical for Padcev, which carries a dose-limiting toxicity of peripheral neuropathy that may increase with exposures. Duration of response was also not yet reached.

DEALS AND FINANCING

Two Claudin18.2 targeting ADCs in the main role of Merck and Elevation Onco’s licensing deals

Elevation Oncology is taking over global rights excluding Greater China to CSPC’s SYSA1801, a Claudin18.2 targeting ADC, for $27 million upfront, plus additional $1.2 billion in milestones. Merck & Co has announced a deal with Kelun Pharma disclosing that the partners will work on early clinical ADC. The only early clinical ADC in Kelun’s pipeline is SKB315, which is targeting Claudin18.2. Merck is paying $35 million upfront, plus another $900 million in milestones.

CytomX is seeking partner to further develop praluzatamab 

CytomX Therapeutics reported that it would discontinue enrollment in two of three arms of a Phase 2 breast cancer trial evaluating praluzatamab ravtansine and seek to partner the therapy due to financial market conditions. The ADC met the primary endpoint of an objective response rate in  Arm A of the study, HR+/HER2-non-amplified breast cancer patients dosed at 7 mg/kg, but did not pass the trial’s futility boundary in triple negative breast cancer, the patient population studied in Arms B and C, for which enrollment will be discontinued. The program is one of its two unpartnered programs in the clinic. The company had $263 million in cash in March.

Qiming, Xia Yan and Taikun co-lead investment in LaNova

Qiming Venture Capital, Xia Yan Capital, and Taikun Fund co-led a Series B round in LaNova Medicines, which the company will use to develop biologic drugs. Shanghai Biomedical Fund also participated in the round; the total amount invested was not disclosed. LaNova’s pipeline comprises more than 10 assets, of which four are in clinical development and another two are expected to enter clinical development this year. The company licensed the ex-China rights to its LM-302 to Turning Point Therapeutics in May for $25 million upfront.