Arcus Biosciences' Q4 2025 update highlights promising 12- and 24-month progression-free survival (PFS) data for the 100 mg casdatifan monotherapy cohort, underscoring durable efficacy and competitive differentiation.
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Can you provide 12‑ and 24‑month PFS rates for the 100 mg cohort at the next data update?
The latest update from Arcus Biosciences on the 100 mg casdatifan (CAS) monotherapy cohort in their ARC-20 study provides important efficacy data relevant to your request for 12‑ and 24‑month progression-free survival (PFS) rates.
Key efficacy metrics reported:
The median PFS for the 100 mg once daily monotherapy cohort is 15.1 months with a median follow-up of 17.8 months. Even under a conservative scenario where all censored patients progress at the next scan, the median PFS would remain robust at 14.4 months 1.
From the Kaplan-Meier curve presented (Slide 12 of the corporate deck), it is noted that a significant number of patients in the 100 mg cohort remain progression-free beyond 12 months and even beyond 24 months, indicating a durable clinical benefit 12.
While an explicit numeric 12‑ and 24‑month PFS rate percentage was not detailed, the statement that "there are quite a lot of patients still on treatment beyond 24 months" implies a meaningful proportion of patients remain progression-free at 2 years or more 12.
The pooled analysis including other cohorts shows a median PFS of 12.2 months with continuing patients beyond 24 months, reinforcing the durability seen in the 100 mg cohort 2.
Contextual considerations:
The 100 mg dose is identified as the optimal, going-forward dose for casdatifan monotherapy with the best-in-class profile versus the only approved competitor, belzutifan, which reported a median PFS of only 5.6 months in a similar setting 123.
Casdatifan's PFS appears to deepen over time, reflecting both early and late responders, with durable responses that may improve the PFS curve tail—a characteristic reminiscent of immunotherapy-like durability 45.
More precise 12- and 24-month PFS rates (e.g., percentage of patients progression-free at those landmarks) are expected to be shared in upcoming presentations, notably at ASCO GU and later in 2026 when more mature Kaplan-Meier data from ARC-20 and combination cohorts (such as cas + cabo) are reported 678.
Summary:
Median PFS: 15.1 months (100 mg monotherapy cohort) with median follow-up of 17.8 months.
12-month PFS rate: Not explicitly reported but implied to be high given median PFS exceeds 15 months and many patients remain progression-free past 12 months.
24-month PFS rate: A substantial number of patients are still progression-free beyond 24 months, signaling a durable effect, though exact percentages are not yet disclosed.
Arcus plans to provide further detailed data updates including survival curves with at least 12 months follow-up on all patients in combination cohorts later this year, which will likely provide explicit numerical 12- and 24-month PFS rates for the 100 mg cohort 678.
References to excerpts:
Median PFS of 15.1 months with 17.8 months follow-up and durable responses beyond 24 months (ARC-20 100 mg cohort) 12.
Confirmation of ongoing patients beyond 24 months from Kaplan-Meier curves 12.
Comparison to belzutifan’s median PFS of 5.6 months shows casdatifan superiority 123.
Expectation of more detailed PFS data including 12‑month minimum follow-up in upcoming presentations 678.
This data underscores casdatifan’s strong efficacy in late-line clear cell RCC and supports confidence in its clinical differentiation based on progression-free survival durability.
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