Novartis' new Zykadia data put first-line nod in sight, but a Roche showdown looms

Novartis HQ cropped

Novartis ($NVS) has some new data in hand that could potentially help cancer med Zykadia snag a first-line indication in ALK+ non-small cell lung cancer. But a rival may get there first.

Friday, the Swiss drugmaker announced that Zykadia--currently approved for patients who fail on Pfizer’s ($PFE) Xalkori--had topped standard chemo at demonstrating improvement in progression-free survival in previously untreated patients. The med also hit its secondary endpoints in objective response rate and duration of response--without turning up any new adverse events.

The pharma giant will be sharing the data with regulatory authorities in the coming months as it eyes a first-line green light, Alessandro Riva, Novartis Oncology’s global head of medical affairs, said in a statement. The company is looking to challenge Pfizer in the first line arena for the 36,000 to 126,000 new patients each year who are candidates for targeted ALK therapy.

But one thing that could hinder Zykadia’s first-line growth, should it nab regulatory go-aheads down the line? Roche ($RHHBY) rival Alecensa, which is gunning for the same indication.

Novartis’ cross-town nemesis released its own results back in May, showing that Alecensa cut the risk of ALK+ NSCLC progression by 66% when compared with Xalkori--and that means Roche may have an edge if both Alecensa and Zykadia make it to the first-line setting.

"It's better to design something against the standard of care," Bank Vontobel analyst Stefan Schneider told Reuters, criticizing the Novartis trial setup that pitted Zykadia against chemo. "Taken from the current data, we assume that Alecensa will be superior to Zykadia from an efficacy and safety perspective in the first line ALK+ non-small cell lung cancer."

Alecensa is already besting Zykadia in the sales department; in the first half of this year, Zykadia generated $48 million in sales compared with Alecensa’s $74 million, and analysts only expect that gap to widen. Analysts expect $320 million in Zykadia sales by 2020, Reuters notes, with Alecensa collecting more than twice that at $700 million. 

- read Novartis' release
- get more from Reuters

Related Articles:
NICE green-lights 5 meds, with discounts turning the tide on PCSK9, Novartis drugs
Novartis grabs Zykadia approval in Europe, setting the stage for showdown
Pfizer nabs speedy FDA review for new use of lung cancer med Xalkori

Read more on