In a significant advancement for
cancer treatment, the FDA has given the green light to a groundbreaking cell therapy for
solid tumors, marking the first approval of its kind. This milestone is anticipated to spur further innovation within the medical field, offering new hope to cancer patients. Over the past ten years, there has been a surge in innovative cancer treatments, leading the FDA to reconsider its traditional approval criteria, focusing more on progression-free survival rather than overall survival.
Looking ahead, the year 2024 is set to deliver pivotal updates for a variety of cancer drugs and vaccines. Among the anticipated treatments are those targeting bladder, breast, lung, and ovarian cancers. BioSpace has highlighted six clinical trials that are expected to reveal their results before the year's midway point.
Daiichi Sankyo and
AstraZeneca are collaborating on Enhertu, an antibody-drug conjugate (ADC) for
metastatic breast cancer. The Phase III DESTINY-Breast06 trial results are eagerly awaited, as they will determine the efficacy of
Enhertu against traditional chemotherapy in patients with
HER2-low, hormone receptor–positive metastatic breast cancer. Enhertu has already proven to be a financial boon for Daiichi, generating over $1.51 billion in revenue in the previous year.
Gilead Sciences'
Trodelvy, initially approved for
metastatic triple-negative breast cancer (TNBC), has seen a substantial increase in sales. The company is optimistic that further approvals could be on the horizon, contingent on the outcomes of the Phase III TROPiCS-04 study. This trial is particularly crucial as it serves as a confirmation of Trodelvy's accelerated approval for
bladder cancer treatment in 2021.
GSK is also making strides with its combination therapy of
Jemperli and
Zejula, which has shown promising results in treating
advanced or recurrent endometrial cancer. The company is now looking forward to the results of another Phase III trial focusing on
ovarian cancer, expected in the first half of 2024.
Roche's anti-
TIGIT immunotherapy
tiragolumab, in combination with
Tecentriq, is under scrutiny in the Phase III SKYSCRAPER-01 study for
non-small cell lung cancer (NSCLC). The study's preliminary data hint at a potential improvement in overall survival for patients treated with the combination therapy.
Cue Biopharma, a lesser-known entity in the field, is also making waves with its lead oncology asset,
CUE-101. The company is anticipating results from the Phase Ib trial, which combines CUE-101 with
Merck's
Keytruda for
HPV-positive head and neck squamous cell carcinoma. Early data have shown a significant response rate compared to Keytruda alone.
Elicio Therapeutics is on the cusp of unveiling data from its cancer vaccine candidate,
ELI-002 7P, which targets
KRAS/
NRAS-mutated solid tumors. The vaccine is designed to act as an adjuvant monotherapy and is being tested in the Phase Ia safety trial of the AMPLIFY-7P study.
As the medical community awaits these pivotal moments in cancer research, the potential for transformative therapies continues to grow, offering a brighter future for patients battling various forms of cancer.
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