Gilead and Arcus Biosciences Announce Promising Phase 3 Lung Cancer Study Update

Gilead Sciences and Arcus Biosciences announced an update on their ongoing Phase 3 clinical study evaluating zimberelimab and domvanalimab in combination with chemotherapy versus pembrolizumab with chemotherapy for non-small cell lung cancer. The study aims to improve overall survival in untreated metastatic patients without specific genomic tumor aberrations. Positive results could enhance investor confidence and market position for both companies.

Gilead Sciences (GILD) and Arcus Biosciences (RCUS) have provided an update on their ongoing Phase 3 clinical study evaluating zimberelimab and domvanalimab in combination with chemotherapy versus pembrolizumab with chemotherapy for non-small cell lung cancer (NSCLC). The study, titled "A Randomized, Open-Label, Phase 3 Study to Evaluate Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy for the First-Line Treatment of Patients With Metastatic Non-Small Cell Lung Cancer With No Epidermal Growth Factor Receptor or Anaplastic Lymphoma Kinase Genomic Tumor Aberrations," aims to improve overall survival in untreated metastatic NSCLC patients without specific genomic tumor aberrations [1].

The study began on October 12, 2022, and is currently recruiting participants. The interventions being tested include zimberelimab and domvanalimab, both administered intravenously, in combination with chemotherapy drugs such as carboplatin, cisplatin, paclitaxel, nab-paclitaxel, and pemetrexed. These treatments are intended to improve survival rates in patients without specific genomic tumor aberrations. The study is designed as a randomized, open-label trial with a parallel intervention model, with participants allocated randomly to receive either the experimental combination or the active comparator, pembrolizumab with chemotherapy [1].

Positive results from this study could enhance investor confidence and market position for both Gilead Sciences and Arcus Biosciences. The study's outcomes could also influence competitive dynamics in the oncology sector, particularly regarding treatments for non-small cell lung cancer. The primary completion and estimated study completion dates are not specified, but the last update was submitted on July 21, 2025 [1].

Separately, HOOKIPA Pharma intends to delist from Nasdaq and dissolve following an asset sale to Gilead Sciences. HOOKIPA Pharma has entered into an asset purchase agreement with Gilead Sciences, which will see Gilead acquire assets related to HOOKIPA's clinical programs for hepatitis B and HIV. A special meeting of stockholders is scheduled for July 29, 2025, to approve the asset sale and the company's dissolution. If approved, HOOKIPA will file for dissolution with the Delaware Secretary of State and cease to comply with certain reporting requirements under federal securities laws [2].

References:
[1] https://www.tipranks.com/news/company-announcements/gilead-and-arcus-biosciences-promising-phase-3-lung-cancer-study-update
[2] https://www.nasdaq.com/articles/hookipa-pharma-inc-announces-intent-voluntarily-delist-nasdaq-and-pursue-asset-sale-gilead