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Week of June 22

This weekly post looks to identify important advancements in the areas of oncology, CNS disorders and neuro-degeneration, technologies, and industry and corporate developments. More in-depth reading and analysis can be found in the attached links.


Oncology


  • Roche announced positive results for Tecentriq in its Phase III study for early TNBC. Tecentriq in combination with chemotherapy met its primary endpoint of pathological complete response regardless of PD-L1 status. Link


  • Eli Lilly revealed positive results for Verzenio in combination with standard adjuvant endocrine therapy in its Phase III study for high-risk HR+, HER2- early breast cancer. Link


  • Roche announced positive results for its combination of ipatasertib with abiraterone in its Phase III study for prostate cancer. Improvements in progression-free survival were identified specifically in PTEN-loss prostate cancers. Link


  • HALO diagnostics released results for their Phase II trial as a part of a 20-year study, suggesting MRI-guided laser focal therapy is safer than standard treatment options for localized prostate cancer. Link


  • AbbVie and Roche announced positive results for its Phase III study in treating previously untreated acute myeloid leukemia (AML) patients. The combination of Venclexta and azacitidine reduced the risk of death by 34%. Link


  • Dana-Farber Cancer Institute in collaboration with Genentech presented findings of a Phase 2 study that Venetoclax with dose-adjusted R-EPOCH may be effective in chronic lymphocytic leukemia (CLL) patients with Richter’s syndrome. Link


  • FDA approved Pfizer’s Mylotarg for newly diagnosed CD33+ AML in infants that are at least one month old. Initial FDA approval in 2017 did not include pediatric patients. Link 


  • FDA granted accelerated approval to Keytruda to treat adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mut/Mb] solid tumors. Link


Technologies


Sarepta Therapeutics announced positive safety and efficacy data for their gene therapy, SRP-9001, in treating Duchenne muscular dystrophy. This is their second release of positive gene therapy results in a month. Link


Industry and Corporate Developments


  • C4 Therapeutics, a biotechnology company pioneering a new class of small-molecule drugs that selectively degrade disease-causing proteins, closed a $170M financing round to advance several drug candidates into the clinic. Link


  • Merck completed its acquisition of Themis Bioscience, fast-tracking its focus on the development of a measles vector-based SARS-CoV-2 vaccine. Link


  • IDEAYA Biosciences and GSK announced a partnership in IDEAYA’s Synthetic Lethality pipeline. GSK’s partnership includes a $20 million equity purchase of IDEAYA, in addition to a $100 million upfront cash payment. Link


  • A US appeals court ruled that the Trump administration cannot enforce regulations requiring drug makers to include list prices in TV ads. This ruling is a victory for Merck & Co., Eli Lilly, Amgen, and the Association of National Advertisers, who sued last year over the proposed regulations. Link


  • The FDA approved Crystiva in treating a rare type of skeletal tumor, tumor-induced osteomalacia. The drug is priced at $200,000 per year. Link

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