Clovis Oncology's late-stage program for the pancreatic cancer drug CP-4126--in-licensed from Norway's Clavis Pharmaceuticals in two pacts totaling $586 million--proved a complete bust. The treatment failed to show an overall survival benefit compared to a gemcitabine arm and found that, contrary to their hypothesis, hENT1 status had no impact on survival.
There's no second act or suggestion of new pathways for CP-4126. Both Clavis (OSE: CLAVIS) and Clovis ($CLVS) are dropping the program entirely, shifting their focus to other development campaigns. But they'll do it with severely crippled stock prices. Clavis shares went into meltdown mode, losing about 90% of their value on the news, while the price of Clovis shares plunged by about 50%.
"The results from the LEAP study are surprising and disappointing given the evidence we have seen from previous studies reported in the literature," says CEO Olav Hellebo. "This is bad news for patients who suffer from metastatic pancreatic cancer, which is a very difficult condition to treat."
For Clavis, its main hope is to change the tune in the investment community with its Phase III study of elacytarabine, which reads out in a few months. A mid-stage study of an elacytarabine/idarubicin combo for acute myeloid leukemia in patients who have failed standard treatment is also underway. "We remain focused on completing the ongoing clinical trials in which elacytarabine is being investigated and in particular look forward to reporting the results from the pivotal Phase III CLAVELA study in the first quarter of 2013," says Hellebo in a statement.
"CP-4126 and elacytarabine have some similarities (both have a fatty acid attached to a parent molecule), but also important differences," Hellebo tells FierceBiotech in an email. "CP-4126 was a hENT1 story while elacytarabine is about increased OS in refractory and relapsed AML patients, irrespective of hENT."
For Clovis, the failure means a shift to a much earlier-stage program, the Phase I/II trial of CO-1686 for non-small cell lung cancer. "We are obviously disappointed with these results, which are unambiguous," said Patrick J. Mahaffy, president and CEO of Clovis Oncology.
- here's the press release