4:17 PM
Apr 12, 2019
 |  BC Extra  |  Clinical News

Clovis down after discontinuing rucaparib bladder cancer trial

Clovis was off $3.08 (13%) to $20.40 in after-hours trading Friday after the company disclosed that it discontinued the Phase II ATLAS trial of Rubraca rucaparib as monotherapy to treat locally advanced unresectable or metastatic urothelial carcinoma.

According to an SEC filing, a preliminary analysis by an IDMC of 62 patients treated with Rubraca showed that the objective response rate (ORR) "does not meet the protocol-defined continuance criteria" and suggests that monotherapy treatment "may not provide a meaningful clinical benefit."

In February, Clovis Oncology Inc. (NASDAQ:CLVS) presented the design of ATLAS at ASCO-GU. At the time, Clovis said it would assess outcomes based on homologous recombination deficiency status, and explore additional biomarkers, including mutant allele frequencies, alterations in genes associated with DNA repair, oncogenic signaling pathways, tumor mutational burden (TMB), microsatellite instability (MSI) and PD-L1 expression. The open-label trial was slated to enroll about 200 patients (see "Broadening the PARP Playing Field").

Clovis said in the filing that it plans to continue evaluating Rubraca as a combination therapy for advanced bladder cancer, and will begin next half a pan-tumor trial that will enroll patients with advanced bladder cancer and selected genetic mutations.

Rubraca is approved for ovarian cancer, and the company plans to submit an sNDA to FDA this year for the drug to treat advanced prostate cancer.

Clovis has rights to the oral small molecule inhibitor of PARP-1, PARP-2 and PARP-3 from Pfizer Inc. (NYSE:PFE).

Clovis lost $0.28 to $23.48 on Friday.

Targets: PARP-1 - Poly(ADP-ribose) polymerase-1; PARP-2 - Poly(ADP-ribose) polymerase-2; PARP-3 - Poly(ADP-ribose) polymerase-3; PD-L1 (B7-H1; CD274) - Programmed cell death 1 ligand 1

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