Please ensure Javascript is enabled for purposes of website accessibility

Clovis Oncology's Failure Is a Big Win for AstraZeneca

By Todd Campbell - Apr 12, 2016 at 6:41PM

You’re reading a free article with opinions that may differ from The Motley Fool’s Premium Investing Services. Become a Motley Fool member today to get instant access to our top analyst recommendations, in-depth research, investing resources, and more. Learn More

A negative vote by a key FDA committee suggests that AstraZeneca might have this important market all to itself.

IMAGE SOURCE: FLICKR USER STOCKMONKEYS.COM.

Following a disastrous drubbing by the Food and Drug Administration's key advisory committee, the future for Clovis Oncology's (CLVS -3.94%) once-promising non-small cell lung cancer drug rociletinib is up in the air. Assuming that the FDA follows the Oncologic Drugs Advisory Committee recommendation and passes on approving rociletinib until it has more late-stage data to parse, then it will leave the door wide open for AstraZeneca plc's (AZN 0.30%) Tagrisso to become a top seller.

Trip and fall
Clovis Oncology's rociletinib targets one of the toughest-to-treat forms of lung cancer and initially reported results from trials evaluating rociletinib suggested it could offer significant new hope to a specific subset of non-small cell lung cancer (NSCLC) patients.

Specifically, rociletinib is being developed for use in NSCLC patients who develop a resistance to commonly used first-line treatments known as TKIs.

NSCLC accounts for about 85% of the 1.8 million new cases of lung cancer diagnosed annually and between 10% to 35% of those NSCLC patients have a mutation to the epidermal growth factor receptor (EGFR), depending on ethnicity. Of those EGFR positive patients, however, as many as 60% develop a resistance to TKI therapy because of a mutation known as T790M.

Because the overall survival rate at five years for these NSCLC patients is poor, mid-stage results suggesting that 53% of patients responded to rociletinib therapy ignited hope that this drug could win approval under the FDA's accelerated pathway.

However, management admitted last November that the response rate was actually far lower than it had previously reported. It turns out that it was only between 28% and 34%.

If safety weren't an issue, that lower response rate might not have been a deal breaker for rociletinib on its own. Unfortunately, roughly half of rociletinib patients suffer from severe adverse events and many of those patients passed away because of them.

Because of the lower efficacy and an arguably worrisome safety profile, the FDA's committee voted 12-to-1 that more late-stage data is needed on rociletinib before it can be approved. Specifically, they want to see the outcome of Tiger 3, a phase 3 trial that isn't expected to wrap up until late in 2018.

IMAGE SOURCE: ASTRAZENECA PLC.

Setting the pace
Clovis' experience with rociletinib is in stark contrast to the experience AstraZeneca had with its own T790M targeting drug, Tagrisso.

Tagrisso went from its first clinical trial to FDA accelerated approved drug in about two -and-a-half years, an unheard-of timeline for cancer drug development.

The company won over FDA regulators last November following compelling mid stage trial data showing an objective response rate, a measure of tumor shrinkage, of 59% in patients, and a duration of response of 12.4 months.

Importantly, while severe adverse events were a problem for Clovis Oncology, Tagrisso's safety profile is arguably solid with the most common adverse events being mild to moderate.

Looking forward
Tagrisso's less dramatic pathway to approval and best-in-class efficacy and safety could have given AstraZeneca the edge even if rociletinib had been approved. However, with rociletinib's approval now unlikely, there's little to stand in the way of Tagrisso becoming a top seller. AstraZeneca has targeted Tagrisso sales of $3 billion annually by 2020, and while that might be a bit aggressive, the absence of a competitor in this indication could make that target more attainable.  

 

Invest Smarter with The Motley Fool

Join Over 1 Million Premium Members Receiving…

  • New Stock Picks Each Month
  • Detailed Analysis of Companies
  • Model Portfolios
  • Live Streaming During Market Hours
  • And Much More
Get Started Now

Stocks Mentioned

AstraZeneca PLC Stock Quote
AstraZeneca PLC
AZN
$66.41 (0.30%) $0.20
Clovis Oncology, Inc. Stock Quote
Clovis Oncology, Inc.
CLVS
$0.68 (-3.94%) $0.03

*Average returns of all recommendations since inception. Cost basis and return based on previous market day close.

Related Articles

Motley Fool Returns

Motley Fool Stock Advisor

Market-beating stocks from our award-winning service.

Stock Advisor Returns
334%
 
S&P 500 Returns
117%

Calculated by average return of all stock recommendations since inception of the Stock Advisor service in February of 2002. Returns as of 05/24/2022.

Discounted offers are only available to new members. Stock Advisor list price is $199 per year.

Premium Investing Services

Invest better with The Motley Fool. Get stock recommendations, portfolio guidance, and more from The Motley Fool's premium services.