CLVS - Clovis stock rises 10% as Rubraca shows survival benefit in prostate cancer in confirmatory trial

Clovis Oncology ( NASDAQ: CLVS ) said its medicine Rubraca helped extend the lives of patients with a type of prostate cancer without their disease getting worse, achieving the main goal of a phase 3 trial.

The study, dubbed TRITON3, enrolled patients with metastatic castration-resistant prostate cancer (mCRPC) with mutations in BRCA or ATM who received Rubraca or the control group, which consisted of doctor's choice of docetaxel, abiraterone acetate [sold as Zytiga by Johnson & Johnson ( JNJ )] or enzalutamide [marketed as Xtandi by Astellas Pharma ( OTCPK:ALPMY ) Astellas ( OTCPK:ALPMF ) and Pfizer( PFE )] , the control group.

Clovis said TRITON3 is the confirmatory study for Rubraca's current U.S. accelerated approval in mCRPC and will also serve as the basis of a supplemental New Drug Application (sNDA) for U.S. label expansion to be submitted during Q1 2023.

Rubraca monotherapy achieved the main goal of significantly improved radiographic progression-free survival (rPFS), compared to the control group, the company said in an Oct. 3 press release.

PFS is the length of time during/after therapy a patient lives with the disease without it getting worse.

Clovis noted that significant improvement in rPFS in patients with BRCA mutation was seen. The median PFS for patients with BRCA mutations treated with Rubraca (n=201) was 11.2 months versus 6.4 months for those on the physician's choice of therapy (n=101).

The company noted that the median PFS for all patients enrolled in TRITON3 and treated with Rubraca was 10.2 months versus 6.4 months for those on physician’s choice.

Rubraca showed statistical significance in all 405 patients randomized in TRITON3, the company added.

In the exploratory subgroup of men with tumor ATM mutations (n=103); median rPFS in the Rubraca arm (n=69) was 8.1 months versus 6.8 months in the control arm (n=34), according to the company

However, Clovis said that the hazard ratio for the interim analysis of the secondary goal of overall survival (OS) in the BRCA subgroup and ITT population, which were not yet mature, favored Rubraca but the hazard ratio for OS in the exploratory subgroup of ATM, which is mature, favored the control arm.

The most common (?5%) treatment-emergent grade 3 or higher adverse events (TEAEs) among all patients treated with Rubraca in the trial were anemia/decreased hemoglobin (23.7%), decreased neutrophil count (7.4%), asthenia/fatigue (7.0%). Safety profile of Rubraca seen in the trial was consistent with Rubraca labelling, the company noted.

In September, Rubraca showed survival benefit as maintenance therapy for ovarian cancer in a phase 3 trial called ATHENA.

CLVS +10.08% to $1.31 premarket Oct. 3

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