Arcus’ HIF-2a Inhibitor Shows Positive Response Rate in Study

The latest research on Arcus Biosciences’ experimental HIF-2a inhibitor suggests that the firm may provide significant competition to Merck’s Welireg in treating kidney cancer.

In the phase 1/1b ARC-20 trial of Arcus’ applicant casdatifan for metastatic clear cell renal cell cancer (ccRCC), the biotech’s HIF-2a inhibitor attained an overall response rate (ORR) of 34%—with confirmation still to come for two responses—and an established ORR of 25%.

According to the firm, the findings were from a 100-mg expansion group that included ccRCC patients whose illness had advanced after receiving at least two previous treatment regimens, which included both an anti-PD-1 agent and a tyrosine kinase inhibitor.

As per the study’s data cutoff on August 30, less than 20% of patients had main progressive illness, as reported by the biotechnology company. According to Arcus, the majority of patients exhibited illness control, characterized by either an incomplete response or stable illness.

The median follow-up duration at that stage of the trial was 11 months. The company reported that the median progression-free survival (PFS) had not been attained by the data deadline period.

Analysts at Evercore ISI were confident in Arcus’ results in a message to clients, noting that the biotech’s medicine showed a small but significant improvement in ORR when compared to a separate study of Merck’s Welireg. Analysts frequently rely on cross-trial comparisons to assess drugs in the absence of direct comparative research, even thought they come with their fair share of problems, such as differences in trial populations and methodologies.

Welireg received its second FDA clearance for relapsing or refractory renal cell carcinoma in December. The medication was originally authorized for the treatment of the rare condition von Hippel-Lindau, which induces tumor development in many organs, predominantly the kidneys.

The Evercore team emphasized casdatifan’s potential in comparison to Merck’s licensed medication, which attained an ORR of just under 23% in the LITESPARK-005 research. They observed that Arcus’ treatment obtained its ORR statistics at a more advanced illness stage and with a reduced follow-up period.

Arcus’ CMO, Dimitry Nuyten, said that the organization is preparing for a phase 3 study of casdatifan in conjunction with Exelixis’ Cabometyx in early 2025. The company intends to broaden its research project for the HIF-2a inhibitor by combining casdatifan with AstraZeneca’s investigational antibody volrustomig in the first-line scenario.

Under the current partnership agreement, Gilead Sciences has the option to engage in the development and marketing of casdatifan after Arcus provides an acceptable data package. Following Thursday’s findings, the Evercore team anticipates that Gilead will likely enter the competition by late 2024 or early 2025.

In 2020, Gilead entered into a comprehensive 10-year agreement with Arcus, including an upfront payment of $175 million for the license to the PD-1 checkpoint inhibitor zimberelimab, along with options for the remainder of Arcus’ pipeline. Gilead obtained the options on three Arcus projects the following year, providing the biotechnology firm with an additional $725 million.

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