Clovis bags rociletinib, leaving AZ's Tagrisso with a clear path to $3B

Targrisso assembly line
(Photo courtesy of AstraZeneca)

More good news for AstraZeneca’s ($AZN) Tagrisso: Last week, Clovis Oncology ($CLVS) quietly canned its lung cancer candidate rociletinib. The drug was already doomed to a long delay after an FDA expert panel spurned its supporting data, which would have given Tagrisso more time to capitalize on its first-to-market status.

Now, Tagrisso is home free in its market niche, with a clear path to its sales target of $3 billion per year.

Reeling from the 12-to-1 panel rejection at the FDA, Clovis said it would ax 35% of its staff and consign rociletinib to the scrap heap. The company stopped all its clinical trials, including the pivotal study on which its FDA app was based, and pulled its approval pitch in Europe.

Not so long ago, rociletinib was considered a potential contender against Tagrisso. Clovis’ late-stage data releases touted response rates more impressive than the AZ drug’s. If the data had held up, that is. The company had been quoting unconfirmed responses, raising eyebrows at the FDA, which already was worried about rociletinib’s side effects.

Then Clovis had to backtrack on response rate when the unconfirmed responses Despite all that, Clovis was expecting an approval during the first half of this year, which would have put its drug only a few months behind Tagrisso’s launch.

As AstraZeneca CEO Pascal Soriot pointed out two weeks ago, it’s been quite the turnabout. “[A] year ago, people thought Clovis had a better product than we did,” Soriot told analysts on the company’s Q1 earnings call. “And then today, they don't have approval and then we have a product that is really making enormous progress.”

Soriot’s right; Tagrisso is doing well so far, with $51 million in first-quarter sales, on top of $19 million between its late November launch and the end of the fourth quarter.

But its blockbuster future isn’t certain. One hurdle is the diagnostic test required to sift out patients with the genetic mutation qualifying them for Tagrisso treatment; as EVP Luke Miels said on the company’s Q1 earnings call, EGFR mutation testing was only at about 10% before Tagrisso hit the scene, so it was hardly a habit for oncologists.

That rate is up to 40%, Miels said, and AstraZeneca expects that to ratchet up further when a new companion diagnostic test comes available later this year. The drug won European approval in February and, more importantly, a Japanese nod soon after.

“Japan is the market with the most potential patients,” Soriot said during the Q1 call, because the EGFR mutation Tagrisso targets is more common in patients of Japanese ancestry, at 65% to 70% of lung cancer sufferers. The company already has almost 2,000 patients in pre-launch access programs.

Of course, the company is also working on new indications for Tagrisso, including a use in previously untreated patients where it would have more competition, but a bigger patient pool to draw from. The company quoted a 77% confirmed response rate among patients in a small Phase I efficacy study, with progression-free survival of 19.3 months. It’s also prepping a study pairing Tagrisso with its PD-L1 immunotherapy durvalumab.

- see the AZ call transcript
- here's the Clovis release

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