Clovis abandons lung cancer drug following FDA mauling

It looks like the end of the road for Clovis' lung cancer drug rociletinib, which, only last year, was tipped as a potential blockbuster by Goldman Sachs with sales of up to $2 billion.

Clovis has abandoned rociletinib, a potential rival to AstraZeneca's Tagrisso (osimertinib), following a bad review by advisers to the US regulator last month.

Colorado-based Clovis said its hopes now lie with ovarian cancer drug rucaparib, which it plans to file in the US and Europe in the coming months, ahead of a potential US launch late this year or early in 2017.

The company said in a Q1 results statement that it expected to receive a rejection letter for rociletinib, from the US Food and Drug Administration (FDA) on or before its regulatory decision date of 28 June.

In anticipation of the rejection the company is laying off staff and contractors working on rociletinib, around 35% of its workforce, saying it has cash reserves of around $445.5 million - enough to fund operations until 2018.

Clovis, which is also developing breast cancer drug lucitanib, has withdrawn a European filing and terminated enrolment in all ongoing studies of rociletinib, including the phase 3 TIGER-3 trial. Patients already receiving the drug in studies will continue to do so.

Last month the FDA's Oncologic Drug Advisory Committee, in a non-binding vote, recommended the regulator should wait until at least late 2018, when results of the trial are due.

The regulator's own staff had raised doubts about rociletinib, which, like Tagrisso, inhibits EGFR and is designed to treat lung cancers with a T790M mutation.

Following two sudden deaths recorded in trial evidence so far, FDA staff reviewers were concerned over risk of torsade de pointes – irregular heart rhythm that can cause sudden cardiac death – and suggested a boxed warning about the risk in draft labelling recommendations.

Other issues raised by the FDA, based on study evidence, included risk of hyperglycaemia. They also noted that some of Clovis's efficacy data was based on unconfirmed data.

Commentators such as TheStreet columnist Adam Feuerstein said in a blog at that time that Clovis should drop the drug.

The biotech's hopes now rest with rucaparib, in phase 3 development for advanced ovarian cancer with deleterious BRCA mutated tumours.

Clovis expects a rolling US filing to be complete in Q2, with a European filing slated for Q4 2016.

Clovis CEO Patrick Mahaffy said: "We are very disappointed in the outcome for rociletinib, as there is a need for additional options for this difficult-to-treat disease. Our focus moving forward is clear: prioritise rucaparib development activity and prepare for its potential US launch, and manage our existing cash into 2018."

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