Exciting Upcoming Clinical Trial Data in Oncology for the First Half of 2024

In the past decade, the field of cancer treatment has witnessed a surge of innovative drugs, prompting the FDA to shift its focus from overall survival to progression-free survival when making approval decisions. Apart from the already approved drugs in 2024, several promising anticancer therapies and vaccines are expected to receive significant approvals. Industry website BioSpace has conducted a detailed analysis of six clinical trials with anticipated results in the first half of 2024. Let's delve into these exciting developments in oncology.

1. Enhertu for HER2-Low, Hormone Receptor-Positive Metastatic Breast Cancer:

Enhertu (trastuzumab deruxtecan), an antibody-drug conjugate (ADC) developed by Daiichi Sankyo and AstraZeneca, is being investigated in the phase III DESTINY-Breast06 trial for the treatment of HER2-low, hormone receptor-positive metastatic breast cancer. The results of this trial are expected to be announced in the first half of 2024. Enhertu has shown promising revenue potential, generating over $1.51 billion in 2023. It is one of the key ADC therapies developed by Daiichi Sankyo. Additionally, a trial comparing another ADC, Dato-DXd, with chemotherapy in triple-negative breast cancer (TNBC) patients, named TROPION-Breast02, will also unveil its preliminary data in 2024. The competition between these ADC therapies will be fascinating to observe.

2. Trodelvy for Second-Line Bladder Cancer:

Trodelvy, developed by Gilead Sciences, was initially approved in April 2020 for the treatment of metastatic TNBC. Its sales in the fourth quarter of 2023 witnessed a growth of over 50% compared to the same period in the previous year. Gilead's CEO, Dan O'Day, emphasized the upcoming results of the phase III TROPiCS-04 trial, evaluating Trodelvy in second-line metastatic bladder cancer. The success of this trial will be crucial for Trodelvy's expansion into the bladder cancer market.

3. Zejula and Jemperli for Ovarian Cancer:

GlaxoSmithKline (GSK) reported positive preliminary data from the second part of the phase III RUBY study, demonstrating the combination of Jemperli and Zejula's efficacy in improving progression-free survival in advanced or recurrent endometrial cancer patients. GSK plans to initiate another phase III trial in the first half of 2024, evaluating the combination therapy in patients with ovarian cancer. This randomized, double-blind study compares Zejula and Jemperli plus platinum-based chemotherapy with standard care platinum-based chemotherapy as first-line treatment for stage III or IV non-mucinous epithelial ovarian cancer. Zejula was previously approved in April 2020 for maintenance treatment in advanced epithelial ovarian cancer patients who have achieved complete or partial response to first-line platinum-based chemotherapy.

4. Tiragolumab and Tecentriq for Non-Small Cell Lung Cancer:

Roche accidentally disclosed the second interim analysis data of the SKYSCRAPER-01 phase III study, evaluating the combination of tiragolumab and Tecentriq (atezolizumab) as a first-line treatment for PD-L1 protein-high expression non-small cell lung cancer (NSCLC). The final analysis of overall survival is expected to take place in the fourth quarter of 2023 or the first quarter of 2024. The study's primary efficacy endpoints are overall survival and progression-free survival. The preliminary data revealed an estimated median overall survival of 22.9 months for the tiragolumab/Tecentriq combination, compared to 16.7 months for Tecentriq monotherapy. These results have sparked significant anticipation for the final analysis.

The first half of 2024 holds great promise for the field of oncology, with several clinical trials set to unveil their results. Breakthrough therapies targeting breast cancer, bladder cancer, ovarian cancer, and non-small cell lung cancer have the potential to reshape treatment paradigms and improve patient outcomes. The outcomes of these trials will determine the future landscape of cancer therapeutics, offering hope to patients and healthcare professionals alike.