On February 16, 2024, a significant milestone in cancer treatment was achieved with the FDA's approval of the first-ever single-session cell therapy for solid tumors, marking an innovative step forward in the field. This approval is expected to spur further advancements and benefit patients significantly. Over the past ten years, there has been a surge in innovation, leading the FDA to consider progression-free survival over the traditional overall survival metric in their approval process. However, this approach may be evolving.
Looking ahead, 2024 promises pivotal updates for various cancer treatments, including those for bladder, breast, lung, and ovarian cancers. BioSpace has highlighted six clinical trials with results anticipated before the year's midpoint.
Daiichi Sankyo and AstraZeneca are collaborating on Enhertu, an antibody-drug conjugate (ADC) for metastatic breast cancer. The Phase III DESTINY-Breast06 trial's outcomes are eagerly awaited, as are those from the TROPION-Breast02 and ASCENT-03 trials, which involve different ADCs for similar cancer types.
Gilead Sciences' Trodelvy, initially approved for metastatic triple-negative breast cancer, has seen a sales boost and could see further growth if upcoming data supports new approvals. The company is also focusing on bladder cancer, with the TROPiCS-04 study being a key confirmation trial following Trodelvy's accelerated approval in this area.
GSK's Zejula and Jemperli are being studied in combination for ovarian cancer. Positive results from the RUBY study's second part have raised hopes for further progress in this area.
Roche's tiragolumab, an anti-TIGIT immunotherapy, is being evaluated in combination with Tecentriq for non-small cell lung cancer (NSCLC). Early data from the Phase III SKYSCRAPER-01 study have been disclosed, with final overall survival analysis expected soon.
Cue Biopharma's CUE-101 is under evaluation for HPV-positive head and neck cancer. The company has reported promising results from a Phase Ib trial, showing a higher overall response rate when CUE-101 is combined with Merck's Keytruda.
Elicio Therapeutics is advancing its cancer vaccine candidate, ELI-002 7P, which targets KRAS/NRAS-mutated solid tumors. Interim data from the AMPLIFY-7P trial are expected to provide valuable insights into this novel therapeutic approach.
In summary, the cancer therapeutics landscape is set to see transformative developments in 2024, with several clinical trials reaching crucial stages and the potential for new treatment options to become available for patients.
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