Week of February 8

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


  • Merck presented results from their head-to-head Phase 3 trial comparing Keytruda in combination with Yervoy (ipilimumab) to Keytruda (pembrolizumab) monotherapy for first line treatment of patients with metastatic PD-L1 positive NSCLC without EGFR or ALK genomic tumor aberrations. The combination therapy did not statistically improve OS (21.9 months vs 21.4 months) or PFS (8.4 months vs 8.2 months) but added toxicity. Link


  • Merck KGaA announced that the FDA has approved Tepmetko (tepotinib) under accelerated approval for the treatment of patients with metastatic NSCLC with mesenchymal-epithelial transition (MET) exon 14 skipping alterations, based on its ORR and duration of response. Link


  • Sanofi’s PD-1 inhibitor Libtayo (cemiplimab-rwlc), received FDA approval to treat advanced basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor (HHI) or where an HHI is not appropriate. This is the first immunotherapy approved in this indication. Link


  • New analysis from a pivotal Phase 3 trial demonstrated that Bristol Myers Squibb’s and Exelixis’s Opdivo (nivolumab) and Cabometyx (cabozantinib) combination, when compared to sunitinib, demonstrated a significantly reduced treatment-related adverse event rate, in addition to continued superior PFS, OS, and ORR in the first-line treatment of advanced renal cell carcinoma (RCC). Link


  • AstraZeneca’s Imfinzi (durvalumab), with or without tremelimumab (ticilimumab), failed to meet either its Phase 3 OS primary endpoint or secondary endpoint in treating PD-L1+ recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) when compared to standard of care in the 1L setting. Link


  • A randomized Phase III trial showed that less invasive approaches for diagnosing prostate cancer are effective. The PRostate Evaluation for Clinically Important Disease (PRECISE) trial, published in JAMA Oncology, demonstrates that using MRI followed by targeted biopsy (TB) demonstrated similar detection rates compared to a systematic 12-core transrectal ultrasonography (TRUS) biopsy. Link


  • Bristol Myers Squibb received FDA approval for their CAR T-cell therapy, Breyanzi (lisocabtagene maraleucel) to treat relapsed or refractory large B-cell lymphoma in the 3L setting. The approval comes three years after Gilead’s Yescarta (axicabtagene ciloleucel) and Novartis’ Kymriah (tisagenlecleucel) approvals to treat various forms of non-Hodgkin lymphoma. Link


COVID-19


  • For an additional $180M, GlaxoSmithKline expanded its collaboration with CureVac to develop a multi-valent mRNA vaccine that could immunize against multiple COVID-19 variants with a single vaccine. In addition to this effort, GlaxoSmithKline will help manufacture CureVac’s current COVID-19 vaccine candidate. Link


Industry and Corporate Developments


  • Coherus Biosciences announced a collaboration and in-licensing deal with Shanghai Junshi Biosciences for their anti-PD-1 antibody, toripalimab. For exclusive rights in the US and Canada, Coherus will co-develop and commercialize toripalimab in addition to the potential option to evaluate combination therapies with Junshi Biosciences’ TIGIT-targeted antibody and next generation engineered IL-2 cytokine. Toripalimab received FDA breakthrough therapy designation to treat nasopharyngeal carcinoma (NPC) in the 3L setting, in addition to receiving FDA’s Fast Track status for the treatment of mucosal melanoma, and FDA’s orphan drug designation for NPC, mucosal melanoma and soft tissue sarcoma. Link


  • In a deal worth $7.2B, Jazz Pharmaceuticals announced the acquisition of GW Pharmaceuticals for their cannabinoid product platform. GW Pharmaceuticals’ lead product, Epidiolex (cannabidiol), designated to treat the two severe early-onset epilepsies Lennox-Gastaut syndrome and Dravet syndrome, is the first prescription cannabinoid to receive FDA approval. Link


  • Veracyte, a genomic diagnostics company, announced its plans to acquire Decipher Biosciences, a commercial stage precision oncology company, through a $600M deal with a goal of expanding its diagnostic reach to 7 of the 10 most prevalent cancers. Link


  • Neurocrine Therapeutics terminated its collaboration with Voyager Therapeutics in developing NBIb-1817 (VY-AADC), a candidate Parkinson’s gene therapy, after the FDA put the Phase II trial on hold due to MRI abnormalities observed in few trial participants. Neurocrine will continue its collaboration with Voyager in advancing their Friedreich’s ataxia program and two discovery programs. Link


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