Date: 2013-10-21
Type of information: Development agreement
Compound: companion diagnostic targeting drug-resistant EGFR mutations to guide the use of CO-1686
Company: Qiagen (The Netherlands) Clovis Oncology (USA)
Therapeutic area: Cancer - Oncology
Type agreement: development
commercialisation
Action mechanism: The diagnostic will build on Qiagen’s therascreen® EGFR RGQ PCR Kit, which was approved by the FDA in July 2013 as a companion diagnostic for use in the treatment of metastatic NSCLC in patients whose tumors have certain EGFR mutations. Analytical performance of the therascreen EGFR test has been established for 21 EGFR mutations, including the most prevalent resistance mutation, T790M. The test supports efficient laboratory workflow with real-time PCR technology on the FDA approved Rotor-Gene Q MDx, which is part of the QIAsymphony family of laboratory solutions.
Disease: non-small cell lung cancer (NSCLC)
Details: * On October 21, 2013, Qiagen has announced a partnership with Clovis Oncology to co-develop and co-commercialize a companion diagnostic test to guide the use of CO-1686, a novel Clovis Oncology product candidate currently in clinical development. The Clovis drug candidate will initially target an unmet clinical need in patients with epidermal growth factor receptor (EGFR) driven non-small cell lung cancer (NSCLC) for whom current EGFR-inhibiting drugs no longer control disease.
The development plan for the companion diagnostic complements Clovis Oncology’s accelerated plan for CO-1686 development by potentially allowing a supplemental premarket approval (PMA) filing for the diagnostic. Subject to regulatory approvals, Qiagen will be responsible for the global development and commercialization of the companion diagnostic, and Clovis will be responsible for the global development and commercialization of CO-1686.
The partners also created the framework for possible future collaborations, thereby adding another master agreement to Qiagen’s growing pipeline of collaborations with some of the world’s leading pharmaceutical and biotechnology companies. Further terms of the agreement were not disclosed.The product is an oral, targeted covalent (irreversible) inhibitor of EGFR.
CO-1686 was designed to selectively target both the initial activating EGFR mutations as well as the T790M resistance mutation. The Phase I dose escalation portion of the study is being conducted in the United States, France and Australia in patients with metastatic or unresectable recurrent NSCLC and a documented EGFR mutation. Patients were not required to be T790M positive for the Phase I portion of the study but had to have progressed on prior EGFR-directed tyrosine kinase inhibitor (TKI) therapy (prior chemotherapy was also allowed). As of October 2013, nineteen patients have been treated in the 900mg BID cohort. Of those nineteen patients, five were T790M negative and fourteen were T790M positive (five non-evaluable). In the nine evaluable T790M positive patients, a 67 percent overall response rate was demonstrated. Six patients achieved RECIST partial responses and two patients achieved tumor shrinkage of 10-20 percent. Patients were heavily pretreated prior to receiving CO-1686; eight of the nine patients had immediately progressed on a TKI prior to treatment. Six of the nine patients received two or more previous TKI lines. As expected, no objective responses were seen in T790M negative patients.
Following the establishment of an appropriate dose, the Company intends to study CO-1686 in Phase II expansion cohorts of NSCLC patients with activating EGFR mutations who have failed initial EGFR-directed therapy and have developed the T790M resistance mutation as well as NSCLC treatment-naïve patients with activating EGFR mutations.
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