CLINICAL AND REGULATORY
Enhertu gains expanded label in new classification of HER2-low patients
Enhertu is a specifically engineered HER2-directed ADC being jointly developed and commercialized by AstraZeneca and Daiichi Sankyo. The approval by FDA was based on the results from the DESTINY-Breast04 Phase 3 trial. In the trial, Enhertu reduced the risk of disease progression or death by 50% versus physician’s choice of chemotherapy in patients with HER2-low metastatic breast cancer with HR-positive disease or HR-negative disease (mPFS 9.9 versus 5.1 months). A median OS of 23.4 months was seen in patients treated with Enhertu versus 16.8 months in those treated with chemotherapy, a 36% reduction in the risk of death.
Enhertu improves PFS vs. physician’s choice treatment
Positive high-level results from the DESTINY-Breast02 Phase 3 trial of Enhertu versus physician’s choice of treatment showed the trial met the primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in PFS in patients with HER2-positive unresectable and/or metastatic breast cancer previously treated with T-DM1. The trial also met the key secondary endpoint of improved overall survival (OS). The trial evaluated a similar later-line patient population as the single-arm DESTINY-Breast01 Phase II trial, which was the basis for initial approvals in advanced HER2-positive metastatic breast cancer. The safety profile of Enhertu in DESTINY-Breast02 was consistent with previous Phase III clinical trials with no new safety concerns identified. Interstitial lung disease (ILD) rates and severity were consistent with those observed in other metastatic breast cancer trials of Enhertu, with a low rate of Grade 5 ILD events observed as determined by an independent adjudication committee.
Trodelvy significantly improves survival in pretreated breast cancer patients
Gilead announced statistically significant and clinically meaningful results from the second interim analysis of the key secondary endpoint of OS in the Phase 3 TROPiCS-02 study evaluating Trodelvy (sacituzumab govitecan-hziy) in patients with HR+/HER2- metastatic breast cancer who received prior endocrine therapy, CDK4/6 inhibitors and two to four lines of chemotherapy.
Early data inform Immunogen’s approach to pivotal ADC study
New data from the Phase 2 CADENZA study of antibody-drug conjugate pivekimab sunirine from Immunogen showed that among four de novo patients with ultra-rare disease blastic plasmacytoid dendritic cell neoplasm (BPDCN), two achieved complete responses; among six with BPDCN and prior or concomitant hematological malignancy, four had complete responses. Based on interactions with FDA, Immunogen will segment the trial into those two populations to reflect the utility of partial hematological recovery as a measure of clinical benefit in the PCHM group. Top-line data are due in 2024; the ADC targets CD123.
PDUFA date for Polivy in first line DLBCL set up for April next year
FDA has assigned a PDUFA date of April 2, 2023 to an sBLA for Polivy polatuzumab vedotin-piiq as Genentech looks to deliver a new treatment regimen for first-line DLBCL. The Roche unit is seeking approval of the anti-CD79b ADC in combination with Rituxan rituximab plus cyclophosphamide, doxorubicin and prednisone. The EC approved Polivy in May for the indication.
DEALS AND FINANCING
Everest extends runway by returning Trodelvy rights to Gilead
Sending Trodelvy sacituzumab govitecan’s Asian rights back to Gilead unit Immunomedics gives $280 million in upfront money to Everest Medicines to invest in its pipeline. Everest is eligible for $175 million in milestones and off the hook for $710 million in potential obligations. In June, Everest gained approval in China for the antibody-drug conjugate targeting TROP2, which it originally licensed in a 2019 deal.
CanWell Biotech raised over RMB100 million in Series A
China-based CanWell Biotech raised more than RMB 100 million ($15 million) in SDIC Venture Capital-led series A+ financing, which the company will use for its immunotherapy, small molecule and ADC pipeline. CanWell was founded by Yu Ninghui, formerly of Merck Serono, and raised a series A financing led by Longpan Investment this year.