Clovis Oncology ($CLVS) is planning to test whether its oral lung cancer drug can work in tandem with a closely watched injectable treatment from Roche's ($RHHBY) Genentech division, hoping to expand the potential for its breakthrough-designated therapy.
The plan is to enroll a Phase Ib/II trial by the end of this year pairing Clovis' rociletinib with Genentech's atezolizumab, which works by blocking an immune checkpoint called PD-L1 to help the body attack tumors. Clovis is targeting patients with non-small cell lung cancer (NSCLC) and mutations in their EGFR genes, using the Phase Ib portion to assess the safety and tolerability of the combo before rolling into Phase II and measuring antitumor activity.
The trial, sponsored by Clovis, could brighten the future for rociletinib if it can demonstrate a positive add-on effect to checkpoint inhibitors, a class of biologics expected to bring in as much as $30 billion a year at its peak. Clovis' drug, an EGFR inhibitor, has won the FDA's coveted breakthrough designation, but some analysts contend that it hasn't meaningfully distanced itself from AstraZeneca's ($AZN) similar AZD9291.
Clovis filed rociletinib, formerly CO-1686, with U.S. and European regulators last week, seeking a standalone approval for NSCLC patients whose cancer has withstood prior EGFR treatment and who carry a mutation called T790M that leads to drug resistance. The company expects to win approvals in both territories and launch the drug next year.
As for Genentech's atezolizumab, the antibody trails a pair of on-the-market treatments from Merck ($MRK) and Bristol-Myers Squibb ($BMY), but the company believes its checkpoint blocker could eventually stand out as the best in its class. Genentech is working through 11 Phase III trials on atezolizumab, working to establish its efficacy in a wide range of cancers while expecting a first approval by 2016.
AstraZeneca is pushing forward with a PD-L1 blocker of its own, trailed by the team of Merck KGaA and Pfizer ($PFE).
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