Clovis soars on upbeat signs of efficacy for targeted cancer drugs

Clovis Oncology managed to capture the spotlight at ASCO this morning with the news that the majority of advanced ovarian cancer patients in an early-stage trial benefited from their PARP inhibitor rucaparib. And in a clinical update Clovis also touted evidence of activity for its early-stage lung cancer drug targeted at EGFR-mutant patients. Its shares ($CLVS) skyrocketed 80% on the news.

It's early days yet for rucaparib. The data released today is based on results seen for 37 patients who had already failed a slate of standard therapies. They've been divided into two groups receiving once- and twice-daily doses. Investigators have been steadily upping the dose in search of the maximum that could be allowed, but Clovis says they have yet to reach the dose ceiling.

Clovis has been recruiting patients with defective BRCA function. And the biotech has already said that if they can demonstrate clear signs of efficacy in early-stage work, its investigators will launch a registration study in the second half of this year. Foundation Medicine has been brought in to develop a companion diagnostic that can be used to identify patients most likely to respond.

"Clinically meaningful results have been seen in the rucaparib monotherapy Phase I trial," said Jonathan Ledermann, a professor at Cancer Research UK. A whopping "89% of patients with ovarian cancer demonstrated a clinical benefit. Increasing evidence suggests that genetic analysis of ovarian tumors can help identify patients who derive benefit from PARP inhibitor therapy--best known predictors are mutations in BRCA genes, either at germline or somatic level, but there are likely other predictive mutations as well. The Clovis development program seeks to exploit these new insights and I am pleased to be jointly leading their larger-scale trials to assess the full clinical potential of this well-tolerated drug in ovarian cancer."

Clovis also released an update on CO-1686, noting that a handful of lung cancer patients in Phase I have demonstrated signs of therapeutic activity. "Objective responses have been observed in heavily pretreated T790M+ patients who are resistant to erlotinib," says the company. "Additionally, metastasis shrinkage has been observed at multiple organ sites, including both brain and liver metastases."

"There are no approved treatment options for patients with non-small cell lung cancer who have developed the T790M resistance mutation," said CEO Patrick J. Mahaffy. "We are extremely encouraged by these initial results which suggest that CO-1686 is well-tolerated and offers clear evidence of meaningful activity in a heavily pre-treated patient population, despite not yet having established our" maximum tolerated dose.

The upbeat news for Clovis follows a failure of its lead drug, partnered with Norway's Clavis.

- see the release on rucaparib
- here's the data on CO-1686