Upcoming 2024 Oncology Trials: First Half Key Results

On February 16th, a landmark event occurred in cancer treatment as the FDA granted approval for the first-ever one-time cell therapy for solid tumors, marking the advent of tumor-infiltrating lymphocytes therapy. This historic decision is anticipated to spur further innovation within the field, offering new hope to cancer patients.

In the last ten years, the pace of innovation in cancer treatment has been remarkable, prompting the FDA to reconsider its traditional reliance on overall survival as the key metric for approval, instead opting for progression-free survival. However, there are indications that this approach may be evolving.

In 2024, a plethora of cancer drugs and vaccines have already received approval, and more significant results are expected soon. These include groundbreaking treatments for a variety of cancers such as bladder, breast, lung, and ovarian. A closer examination reveals six clinical trials that are expected to release results by mid-year.

Daiichi Sankyo and AstraZeneca's collaboration has led to the development of Enhertu, an antibody-drug conjugate (ADC) that has shown promise in treating metastatic breast cancer. The Phase III DESTINY-Breast06 trial's results are eagerly awaited, as they will provide insights into the efficacy of Enhertu against traditional chemotherapy methods in HER2-low, hormone receptor–positive metastatic breast cancer.

Gilead Sciences' Trodelvy, initially approved for metastatic triple-negative breast cancer (TNBC), has seen a significant increase in sales and could potentially see an even greater rise if future trials support additional indications. The Phase III TROPiCS-04 study will provide crucial data on the drug's effectiveness in second-line metastatic bladder cancer.

GSK's Zejula and Jemperli are also under scrutiny, with positive results from the Phase III RUBY study indicating improved progression-free survival in patients with advanced or recurrent endometrial cancer. The upcoming Phase III trial for ovarian cancer is expected to yield results in the first half of 2024.

Roche's tiragolumab, an anti-TIGIT immunotherapy, is being studied in combination with Tecentriq for non-small cell lung cancer (NSCLC). The Phase III SKYSCRAPER-01 study's early data release has heightened interest in the final overall survival analysis, expected in the coming months.

Cue Biopharma, a lesser-known entity, is also making waves with its lead oncology asset, CUE-101. The biologic is being tested in combination with Merck's Keytruda for HPV-positive recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC), with early results showing a higher overall response rate compared to Keytruda alone.

Elicio Therapeutics is gearing up to present data from its cancer vaccine candidate, ELI-002 7P, which targets KRAS/NRAS-mutated solid tumors. The interim data from the Phase Ia safety trial will be a significant milestone for this therapeutic vaccine.

The landscape of cancer treatment is rapidly changing, with a variety of novel therapies and vaccines in the pipeline. The upcoming results from these trials are expected to further advance the field, offering more targeted and effective treatments for a range of cancers.