This week our industry news insights look at a new FDA committee to be established on digital health technologies, the new Nobel Prize laureates for 2023, and Merck’s interim analysis of the KEYNOTE-671 trial.
The US Food and Drug administration has established a new committee to advise on the implications of digital health technologies. This new committee – set to be established in 2024 – will look into a range of digital technologies including, artificial intelligence and machine learning, augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring, and software.
The Nobel Prize in Physiology or Medicine 2023 has been awarded to Katalin Karikó and Drew Weissman for their discoveries that led to the development of mRNA vaccines against COVID-19.
Karikó and Weissmann have been investigating mRNA since the early 1990s. Initially hampered by the immunogenicity of mRNA, they discovered a specific chemical modification that resulted in mRNA being taken up by cells without an immune response. This discovery changed the understanding of how mRNA interacts with the immune system and contributed to the unprecedented rate of vaccine development during COVID-19. These discoveries were not without hurdles, with their key paper in 2005 being rejected by both Nature and Science.
Merck’s KEYNOTE-671 trial meets the dual primary endpoint of overall survival in resectable Stage II, IIA, or IIIB non-small cell lung cancer.
The KEYNOTE-671 trial is investigating KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy. Merck announced that at a pre-specified interim analysis, Keytruda plus chemotherapy before surgery followed by resection and Keytruda as a single agent after surgery, has demonstrated a statistically significant and clinically meaningful improvement in overall survival compared to neoadjuvant placebo plus chemotherapy followed by adjuvant placebo. This comes ahead of the pending FDA decision on whether to include this indication on Keytruda’s therapy label.
