UPDATED: Clovis preps for a blockbuster showdown with AstraZeneca

CHICAGO--Clovis Oncology has come out of the gate at ASCO with updated--and promising--data on its targeted lung cancer drug CO-1686, offering fresh evidence of its durability and effectiveness. In what's shaping up as a head-to-head showdown with a resurgent AstraZeneca ($AZN), the biotech says it's been tracking a progression-free survival rate that has pushed past the important 12-month mark in an early-stage study while registering a 58% objective response rate among a particular group of patients most likely to respond.

That 58% response rate is a little lower than what it's reported before. It also lags behind the 64% rate that was recently reported for AstraZeneca's rival AZD9291. But Clovis ($CLVS) CEO Patrick Mahaffy tells FierceBiotech that he's confident that come approval time, his drug will continue to look remarkably similar to AstraZeneca's therapy in terms of efficacy, with a response rate in the high 50s and 60s, while looking to distinguish itself with a better safety profile and solid evidence of a long-lasting impact on many patients.

Both drugs are designed to target EGFR-positive lung cancer, with a distinctly enhanced efficacy profile among patients with the T790 mutation. Both are now designated as breakthrough drugs at the FDA. And both development teams have a lot to prove.

For Clovis, a 2009 Fierce 15 company, this is a chance to distinguish a lead therapy that is intended to barrel straight into the hands of regulators in the middle of next year--with a shot at gaining an approval and launching its first commercial ops in the U.S. before the end of 2015. For AstraZeneca, which has attached a whopping $3 billion peak sales figure to their drug, it's an absolutely essential avenue for establishing that the company can actually get a drug through the clinic and on to an approval. AZD9291 is one of two cancer drugs at AstraZeneca--with MEDI4736--that are attracting close attention from analysts at ASCO.

"We're going really fast," Susan Galbraith, head of oncology iMED at AstraZeneca, tells FierceBiotech, "with the fastest-enrolling Phase I I've ever seen."

Galbraith was also on hand at ASCO, representing a company that is absolutely determined to prove that it's fundamentally shifted gears in R&D. In this case, AstraZeneca has said that it plans to file for an approval in the second half of next year. But Galbraith also added that the company has accelerated the timeline for this drug--designated a "breakthrough" by the FDA--before. And the company may be leaving the door open to another forward shift.

AstraZeneca already has an extensive commercial presence globally, says Galbraith, noting a leading role in key Asian markets. 

Clovis's Mahaffy, though, seems to be enjoying the showdown with a Big Pharma rival with lots to prove.

"We're seeing some really encouraging evidence of durability," he says. adding that the 12 months-plus now on the table comes when Boulder, CO-based Clovis "is not even near the median." So the number should continue to rise. Both drugs, he says, are "clearly very active, which is great news for patients."

This particular group of treatment-resistant patients represents about 15% of the total in the U.S. and Europe, but closer to 35% in Asia. Mahaffy isn't anticipating a near-term deal, but he says that the plan now is to build the structure needed to manage commercial launches in the U.S. and Europe while finding an experienced partner to handle the Asian markets.

CO-1686 came out of Avila, later acquired by Celgene ($CELG), through a $209 million pact inked back in 2010. Most of that cash is back-ended in the deal, which Mahaffy says included a modest $2 million upfront payment.

(Follow up: Come end of day on Monday, Clovis shares were down somewhat after Mahaffy revealed over the weekend that several patients on his drug had to be given insulin to control their blood sugar levels after they developed a resistance to metformin. That's not what investors wanted to hear, especially in light of the head-to-head contest that Clovis is facing. AstraZeneca's drug, meanwhile, was linked to several cases of interstitial lung disease-like reactions.)    . 

- here's the release

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