Endocyte's Good News Double Hits the Target with Investors

March 24, 2014 Endocyte’s good news double hits the target with investors

Lisa Urquhart

In the bears versus bulls battle for Endocyte’s shares, chalk one up for the bulls. Shares in the group more than doubled last week thanks to a twin helping of positive news over its lead compound, vintafolide. The project came up trumps, scoring a positive opinion in ovarian cancer with European regulators and showing significant progression-free survival in a phase II non-small cell lung cancer trial.

However, the share price reaction on a day when the rest of the sector was having a torrid time demonstrates just how uncertain it had been whether the EU would give the nod, and whether the agent would come good in lung cancer. Now the next big catalyst will be whether Endocyte manages to file vintafolide in ovarian cancer in the all-important US market.

Still a way to go

Although some of the uncertainties about vintafolide and its companion diagnostic test etarfolatide might have been removed following Friday, others remain (Upcoming events: European decision for Endocyte and data for Exelixis, March 7, 2014).

The conditional approval in Europe is only that – conditional – and full approval will come from results in the much larger Proceed trial, which Endocyte is hoping will verify the subgroup findings that the project is effective in women who are FR++. Topline progression-free survival (PFS) data are due in the first half of the year.

The results of the Proceed trial, which is the only one being funded by Endocyte's partner Merck & Co, will also form the basis of the pivotal US filing. But again there are doubts whether the use of PFS without the gold- standard of overall survival (OS) will be enough.

Positive trending

In the phase IIb results announced on Friday from the Target trial, which pitched vintafolide and docetaxel against docetaxel alone in a second-line setting for NSCLC, the combination therapy reduced the risk of disease progression or death by 25%. There was no detail on the secondary endpoint of OS, which is the one on which regulators are increasingly focusing in their decisions.

Endocyte did, however, report that it had seen trends in favour of OS in the combination arm and that median OS had yet to be reached. The project also showed better activity in patients with adenocarcinoma.

It is perhaps these bits of news that were the biggest spur to Endocyte’s share price rise, as little had been expected in this indication.

But what should be borne in mind are the many molecules for NSCLC that have initially showed great promise in phase II only to fail at phase III. As such, the detailed results of the Target trial and any update on OS will be eagerly awaited.

However, one thing that the results will have done, other than spark the inevitable takeout rumours, is make Merck plough on with a partnership it spent $120m in up-front fees to secure.

To contact the writer of this story email Lisa Urquhart in London at [email protected] or follow @LisaEPVantage on Twitter