Will it be a green light for CAR-T ambitions, or a U-turn?
Stepping into 2024, CAR-Ts are balancing dual realities. On one side of the coin, CAR-Ts have shown their potential in earlier treatment lines (e.g. Carvykti in CARTITUDE-4 in multiple myeloma (MM)) and the ambition for the class doesn’t stop there.
However, on the flip side, the FDA investigation into secondary malignancies has very recently unfolded to reveal a class-wide black-box warning (for BCMA- and CD19-directed genetically modified autologous T cell immunotherapies). With regulatory decisions for Carvykti (moving into 2L MM) and Abecma (moving into 3L MM) pending,
Spotlight on SKYSCRAPER-01; a moment of truth for TIGIT?
Once hailed as ‘the next big thing in IO,’ anti-TIGIT therapies have faced setbacks, leading to a waning enthusiasm and programme cutbacks. All eyes are now focused on SKYSCRAPER-01, a pivotal trial in this space. The study has reported that the combination of tiragolumab plus atezolizumab failed to show a significant improvement in PFS over atezolizumab alone in 1L PD-L1 high mNSCLC. However, a second interim analysis hints at a potential survival benefit, elevating anticipation for the final analysis.
Investing in personalised cancer vaccines: will the bet pay off?
Personalised cancer vaccines chart an innovative course in the future of immuno-oncology, spurred by the success of KEYNOTE-942. The end of 2023 witnessed a surge in new trials exploring these vaccines across various cancer types and stages, including mid to late-stage trials covering resected melanoma, NSCLC, pancreatic ductal adenocarcinoma, colorectal cancer, HNSCC as well trials in the advanced/metastatic setting in melanoma, and metastatic microsatellite-stable colorectal cancer. And Moderna and BioNTech say there is more to come 1,2. Additionally, this year promises interim results from GRANITE, a phase II/III trial investigating a dual vaccine therapy for metastatic microsatellite-stable colon cancer.
Can ADCs pack the same punch in NSCLC?
ADCs will stay in the spotlight in 2024, especially as we continue the quest to define their role in NSCLC. Despite Dato-DXd’s positive data from TROPION-Lung01, recent setbacks with Sacituzumab Govitecan and Sanofi’s CEACAM5 ADC have dimmed the outlook for ADCs in 2L NSCLC. Important readouts that will shape the outlook:
- EVOKE-01 detailed results:
Is a more refined patient segmentation the key to success in 2L, with Gilead reporting better outcomes for non-responders to IO? - ADC + IO combinations in 1L:
Anticipation grows for IO as the ideal partner for ADCs and trials investigating TROP-2 ADC + IO in 1L are poised to deliver data in the coming year. - Different targets:
Will the success come from more targeted approaches e.g. HER3-DXd in EGFR mutant NSCLC? Following the success of HERTHENA-Lung01, we await regulatory decisions and first results from HERTHENA-Lung02.
To discuss how anticipated developments might impact your oncology portfolio and how Beyond Blue can partner with you, get in touch: oncology@beyondblueinsight.com
References:
1. BioNTech (2024, January 09). BioNTech Outlines 2024 Strategic Priorities at the 42nd Annual J.P. Morgan Healthcare Conference [Press Release]. https://investors.biontech.de/news-releases/news-release-details/biontech-outlines-2024-strategic-priorities-42nd-annual-jp
2. Moderna (2024, January 08). Moderna Provides Business and Pipeline Updates at 42nd Annual J.P. Morgan Healthcare Conference [Press Release]. https://investors.modernatx.com/news/news-details/2024/Moderna-Provides-Business-and-Pipeline-Updates-at-42nd-Annual-J.P.-Morgan-Healthcare-Conference/default.aspx