Week of February 15
This weekly post looks to identify important advancements in the areas of oncology, CNS disorders and neurodegeneration, technologies, and industry and corporate developments. More in-depth reading and analysis can be found in the attached links.
Oncology
Results from a Phase 3 trial demonstrated that Johnson & Johnson’s Erleada (apalutamide), Zytiga (abiraterone acetate), and prednisone combination met its radiographic progression-free survival (rPFS) primary endpoint to treat chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC). Compared to placebo, Zytiga, and prednisone, mCRPC patients had a 31% reduction in the risk of radiographic progression or death. Link
Bayer presented a new analysis of their Phase 3 trial treating non-metastatic castration-resistant prostate cancer (nmCRPC) with Nubeqa (darolutamide) and Xofigo (radium-223 dichloride). nmCRPC patients receiving the Nubeqa combination had a clinically significant OS benefit compared to a placebo combination control. Link
The FDA granted priority review for Amgen’s sotorasib to treat KRASG12C mutated locally advanced or metastatic NSCLC in the 2L setting. The priority review is based on Phase 2 results recently presented at the International Association for the Study of Lung Cancer (IASLC) 2020. Link
AstraZeneca’s and Daiichi Sankyo’s antibody drug conjugate Enhertu (trastuzumab deruxtecan) received conditional authorization in the UK to treat unresectable or metastatic HER2+ breast cancer in the 3L setting. This approval comes a month after the EU’s conditional approval of Enhertu monotherapy in treating HER2+ breast cancer patients. Link
Merck’s Keytruda (pembrolizumab) plus Eisai’s Lenvima (lenvatinib) demonstrated clinically meaningful improvements in PFS, OS, and ORR compared to Pfizer’s Sutent (sunitinib) in 1L advanced renal cell carcinoma. The PFS and OS improvements were consistent across prespecified risk groups (favorable, intermediate, and poor). Link
CNS Disorders and Neurodegeneration
AC Immune, a Switzerland-based clinical stage biopharmaceutical company, announced positive interim results of their Phase 1b/2a study evaluating their anti-phospho-Tau (pTau) vaccine candidate ACI-35.030 for the treatment of Alzheimer’s disease. No early AD participants who received the vaccine had clinically relevant adverse events and all had a potent antigen-specific antibody response against pTau. Link
Industry and Corporate Developments
AbbVie and Caribou Biosciences announced a chimeric antigen receptor (CAR)-T cell research and development collaboration and license agreement worth up to $300M. This collaboration looks to address rejection of allogeneic CAR-T cells by utilizing Caribou's CRISPR genome editing platform to engineer CAR-T cells to withstand the patient’s immune attack. Link