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New Data Presented at ESMO Virtual Congress 2020 Highlight Breadth and Potential of Clovis Oncology Products and Pipeline

  • Initial data from the Phase 1b part of the LIO-1 trial of lucitanib combined with Opdivo® (nivolumab) in advanced metastatic solid tumors identify a recommended Phase 2 dose and show promising signs of antitumor activity
  • The first presentation of preclinical data for FAP-2286, a novel peptide-targeted radionuclide therapy (PTRT), show the compound potently and selectively binds fibroblast activation protein (FAP); compelling anti-tumor activity was observed in FAP-expressing tumor models
  • New data analyses from pivotal Rubraca® (rucaparib) studies ARIEL3 and TRITON2 further characterize its safety profile in recurrent ovarian cancer and metastatic castration-resistant prostate cancer (mCRPC), respectively
  • Encouraging initial data from the SEASTAR study evaluating Rubraca in combination

Clovis Oncology, Inc. (NASDAQ:CLVS) today announced the data being presented as e-posters at the European Society for Medical Oncology (ESMO) Virtual Congress 2020. These include initial data from the Phase 1b part of the LIO-1 study of lucitanib in combination with Opdivo, new analyses of data from the pivotal Rubraca ARIEL3 and TRITON2 studies, initial data from the Phase 1b part of the SEASTAR study arm of Rubraca with Trodelvy™ (sacituzumab govitecan-hziy), and the first presentation of preclinical data for FAP-2286 Clovis’ novel peptide-targeted radionuclide therapy.

“We are very pleased to present these encouraging initial datasets for our pipeline compounds lucitanib and FAP-2286 today, as well as data further characterizing and confirming the established safety profile of Rubraca in advanced ovarian and prostate cancers, which we believe provides additional, valuable information to physicians and their patients,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “We are enthusiastic about the potential of our clinical development programs for each of our three compounds and remain committed to exploring the full depth and breadth of our pipeline to transform the cancer treatment landscape and hopefully improve outcomes for patients.”

Data presented today from the Phase 1b part of the Phase 1b/2 LIO-1 study in patients with an advanced solid tumor (n=17) have identified the recommended starting Phase 2 dose of oral lucitanib to be used in combination with Opdivo and have shown promising signs of antitumor activity. The recommended oral starting dose of lucitanib was established as 6 mg once daily, to be given in combination with Opdivo at a fixed dose of 480 mg intravenously (IV) once every 28 days. Across three dose levels studied (6 mg, 8 mg and 10 mg) of oral lucitanib in combination with intravenous (IV) Opdivo at (480 mg once every 28 days), only one dose-limiting toxicity of Grade 3 proteinuria was observed among 17 patients, and there were no apparent differences in treatment-emergent adverse event (TEAE) frequencies between dose levels. In this small patient population, TEAEs were consistent with those expected for lucitanib and Opdivo. Grade 3 TEAEs included hypertension (n=4), diarrhea (n=1), and proteinuria (n=1); treatment-emergent hypertension was otherwise grade 1 or 2 (n=4), and readily managed with close monitoring and early hypertensive therapy. No grade ≥4 adverse events were reported. Given lucitanib’s relatively large inter-patient pharmacokinetic variability, a safety-based dose-titration approach is being used for the Phase 2 part of the study to optimize lucitanib efficacy as well as safety and tolerability. Among the 17 patients treated, 15 were evaluable for RECIST response as of the efficacy cut-off date: these include one patient with a confirmed complete response, one patient with a confirmed partial response, 10 patients have had a best response of stable disease and three patients had progressive disease. As of August 11, 2020, seven of the 17 patients remained on study, including the two responders and five of the patients with stable disease.

“We have completed enrollment in the Phase 1b part of the LIO-1 trial, and have identified a dose of lucitanib to take into Phase 2 combined with nivolumab. The combination showed promising signs of activity in unselected solid tumors in patients with very advanced disease, including one patient with a confirmed complete response,” said Dr. Erika Hamilton, Director of the Breast and Gynecologic Research Program, Sarah Cannon Research Institute at Tennessee Oncology. “We were also encouraged by the initial safety profile, in particular as it relates to constitutional side effects, and hope to build on that with our dose-titration approach in the ongoing Phase 2 part of the LIO-1 study. This will provide greater understanding of what this combination may offer for the treatment of patients with gynecological cancers.”

In addition to data from the Phase 1b part of the LIO-1 study, a Trials in Progress (TiP) poster describing the study design of the Phase 2 part of LIO-1 was presented. The Phase 2 part of the study is currently enrolling patients to evaluate the efficacy and safety of the lucitanib and Opdivo combination in patients with advanced gynecological solid tumors, including ovarian, endometrial and cervical cancers. As described in the e-poster, a safety-based dose-titration approach is being used for lucitanib dosing to manage tolerability and maintain dose intensity.

Investigators also presented today new safety data analyses from the pivotal Rubraca studies ARIEL3 and pharmacokinetic (PK) analyses of TRITON2, providing additional information to healthcare professionals that can help support their ovarian and prostate cancer patients being treated with Rubraca.

The ARIEL3 data presented in an e-poster reinforce the overall safety profile of Rubraca as a maintenance treatment in patients with recurrent ovarian cancer. After two years of additional follow up for those patients who continued on treatment in the study, the safety profile remains consistent with previous reports, with no new safety signals identified. As of the current safety data cutoff (December 31, 2019), 33 of 372 and 1 of 189 patients in the safety population were still receiving Rubraca or placebo, respectively. Median treatment duration was 8.3 months in the Rubraca arm and 5.5 months in the placebo arm. Prevalence of any-grade nausea declined progressively over the 24-month evaluation period, and prevalence of any-grade anemia/decreased hemoglobin peaked at month 4, decreasing to a plateau after month 8. The first onset of frequently reported TEAEs generally occurred early in treatment (≤45 days). The median duration of the first event of frequently reported TEAEs was generally <60 days.

Population pharmacokinetic (PK) analyses of 199 men with mCRPC receiving Rubraca in the TRITON2 study suggest there is no difference in Rubraca PK in men with mCRPC and women with ovarian cancer based on a comparison to a previously-developed …

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