Week of December 7

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


  • AbbVie reported positive long-term (6.5 years) analyses from two Phase 3 trials for Imbruvica (ibrutinib) in front-line treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). In both trials, Imbruvica demonstrated similar PFS and ORR in patients with or without high-risk genomic aberrations. Link


  • The United Kingdom’s National Health Service (NHS) announced a commercial partnership with Grail to make early cancer detection blood test available to patients. Starting in 2021, the plan is to pilot Grail’s multi-cancer early detection blood test, Galleri, in 140,000 patients with no suspicion of cancer and 25,000 patients with suspicious signs or symptoms of cancer. Link


  • Janssen submitted a Biologics License Application (BLA) to the FDA, seeking approval for amivantamab in treating mNSCLC patients with EGFR mutations. Having received Breakthrough Therapy Designation from the FDA in March 2020, amivantamab is a fully-humanized, bispecific antibody against EGFR and mesenchymal epithelial transition factor (MET), which targets tumors with activating and resistant EGFR and MET mutations. Link


  • In Phase 3 trials, Jazz Pharmaceuticals’ combination of Zepzelca and doxorubicin did not meet the primary endpoint’s pre-specified significance of overall survival (OS) in patients with small-cell lung cancer, though secondary endpoint and subgroup analyses were characterized as favoring the combinational therapy. Link


  • FDA approved a diagnostic agent for PET imaging of PSMA-positive lesions in prostate cancer. Gallium 68 PSMA-11, which binds to prostate-specific membrane antigen (PSMA), will be used in patients with suspected prostate cancer metastases or disease recurrence. This diagnostic agent was developed by nuclear medical teams at UCLA and UCSF. Link


  • Teneobio reported the initial results of an ongoing open-label multi-center trial Phase I trial to treat relapsed refractory multiple myeloma. TNB-383B is a fully-humanized bispecific antibody that targets BCMA on cancer cells and CD3 on the surface of T cells to trigger lysis of multiple myeloma cells. The bispecific antibody achieved an ORR of 80%, with 75% of the responders having a very good partial response (VGPR), and demonstrated a favorable safety profile. Link


  • Reporting an ORR of 97% and a CR rate of 67% in treating multiple myeloma patients, Johnson & Johnson and Legend Biotech announced their plan to file for FDA approval for their anti-BCMA CAR-T cell therapy ciltacabtagene autoleucel by the end of this year. Link


  • Gavreto (pralsetinib), from Roche and Blueprint Medicine, received FDA approval to treat pediatric and adult patients with metastatic rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC). Gavreto is approved to treat RET-alterations in multiple tumor types including NSCLC. Link


CNS Disorders and Neurodegeneration


  • Silo Pharma announced an investigator-sponsored study agreement with Maastricht University of the Netherlands to conduct a Phase 2B clinical trial assessing the effects of repeated low doses of psilocybin and LSD on cognitive and emotional dysfunctions in Parkinson’s disease. The primary endpoint is focused on improvements related to the quality of life and biological markers of neuroplasticity. Link


Technology


  • Janssen Pharmaceuticals acquired the rights to experimental gene therapy, Hemera Biosciences’ HMR59, to treat patients with late-stage age-related macular degeneration. HMR59, a AAV2 gene therapy administered intravitreally, is designed to specifically increase the expression of a soluble form of CD59 in retina cells, in hopes of preventing further damage to the retina and preserving vision in macular degeneration patients. Link


Industry and Corporate Developments


  • AbbVie and Frontier Medicines announced a global strategic partnership to discover, develop, and commercialize a pipeline of novel therapies and E3 degraders against difficult protein targets. Link


  • McKesson and Amgen signed a multi-year strategic agreement to improve patient care in community oncology settings. The focus of the agreement is to reduce lapses in cancer patient care by increasing access to precision medicine resources in these community settings. Link