Clovis Oncology, Inc. (NASDAQ: CLVS) today announced anticipated development milestones and financial guidance for 2013. Clovis currently has two clinical development programs and one drug discovery program underway.
A novel, oral, mutant-selective covalent inhibitor of EGFR mutations in non-small cell lung cancer (NSCLC), CO-1686 is currently the subject of an accelerated second-line development program. Clovis anticipates completing the following milestones in 2013 for CO-1686:
- Complete dose escalation portion of Phase I/II study to establish the dose and schedule;
- Initiate expansion cohorts of Phase I/II study to assess efficacy in second-line T790M+ NSCLC patients and in first-line mutant EGFR NSCLC;
- Initiate use of Roche Molecular Systems diagnostic test to identify T790M+ patients; and
- Prepare to initiate pivotal study in second-line T790M+ NSCLC patients in the first half of 2014.
An oral inhibitor of PARP-1 and PARP-2, rucaparib is being explored in ovarian and breast cancer patients with BRCA mutations and other DNA repair deficiencies. Clovis anticipates completing the following milestones in 2013 for rucaparib:
Mutant c-KIT inhibitor discovery program
- Complete dose escalation portion of Phase I/II study to identify the monotherapy dose and schedule;
- Initiate expansion cohort of Phase I/II study to assess efficacy in selected ovarian cancer patients;
- Initiate Phase II biomarker validation in selected ovarian cancer patients to correlate clinical responses with patient genotype and inform the analysis of the pivotal trial;
- Advance development of diagnostic test with Foundation Medicine to identify patients with BRCA mutations and other DNA repair deficiencies most likely to respond to rucaparib;
- Initiate pivotal study of rucaparib as maintenance therapy in selected platinum-sensitive ovarian cancer patients in the second half of 2013.
During 2012, Clovis entered into a collaboration with Array BioPharma Inc. to discover a novel KIT inhibitor targeting the resistance mutations that occur in the majority of gastrointestinal stromal tumor patients and result in disease progression. This collaboration will continue in 2013 with a goal of identifying a lead compound in late 2013 or early 2014.