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Novartis seeks first-line use for lung cancer drug Zykadia

Looks to go head-to-head with Pfizer/Merck KGaA’s Xalkori and Roche’s Alecensa

Novartis' Zykadia has outperformed standard chemotherapy in previously untreated patients with ALK-positive non-small cell lung cancer, setting up regulatory filings in the coming months.

New ALK inhibitor Zykadia (ceritinib) was given accelerated approval in the US in 2014 as a treatment for ALK-positive NSCLC patients whose disease had progressed despite prior therapy with Pfizer/Merck KGaA's ALK blocker Xalkori (crizotinib), with EU conditional approval coming through last year.

Patients taking Xalkori invariably relapse, often within 12 months of starting treatment with the drug, due to the development of resistance in tumour cells.

In the phase III trial, Zykadia extended progression-free survival (PFS) when compared with standard chemotherapy - including maintenance - and also increased the overall response rate as well as the duration of response, according to Novartis. The company says it intends to present the data in full at a future medical congress.

"Zykadia has proven to be an important treatment option for ALK+ NSCLC patients who have progressed following treatment with crizotinib," said Novartis head of oncology development and medical affairs, Alessandro Riva.

"We are pleased to see these topline results show promise in untreated patients with advanced disease, and look forward to sharing these data with regulatory authorities in the coming months."

Zykadia has been growing slowly for Novartis with sales of $48m in the first half of the year. A shift into first-line use would increase the number of patients eligible to receive the drug and allow Novartis to compete head-to-head in the market with Pfizer and co-promotion partner Merck.

Analysts believe Zykadia will still face a tough challenge in the market however as it goes in pursuit of Xalkori, which brought in $275m for Pfizer in the first six months of 2016. The reason is that a third ALK inhibitor - Roche's recently-launched second-generation rival Alecensa (alectinib) - seems to be gaining considerable traction in the market.

Alecensa sales reached $74m in the first half of the year, suggesting it is making faster headway in the market than Novartis' drug - despite launching several months later - although it does come with a higher price tag.

Roche's drug looks set to consolidate its position following the release of data from the Japanese arm of the head-to-head ALEX trial at this year's American Society of Clinical Oncology (ASCO) congress, which found a significant PFS improvement for Alecensa over Xalkori.

Full data from the entire cohort is due for publication next year, but the Japanese arm is already leading to speculation that Alecensa has a best-in-class profile that could see it mount a strong challenge to Xalkori.

There is still a lot of data to come that could alter the picture however. Clinicians are already discussing among themselves the best order in which to use the drugs - or even use in combination - in order to minimise resistance and extend PFS.

Meanwhile, the ALK inhibitors are all being tested in combination with other drugs - including new immuno-oncology agents - and the outcome of those studies could change the picture dramatically.

Article by
Phil Taylor

23rd September 2016

From: Research, Regulatory



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