Novartis's Zykadia gets positive results, faces Roche pressure

Zurich : Novartis's Zykadia drug performed well against a rare form of lung cancer, the Swiss company said, citing a study it hopes will help it win expanded regulatory approval for the use of the drug.

But it faces competition from a medicine produced by rival Roche that some analysts say may already have the upper hand.

Novartis released results of a phase III clinical trial of Zykadia, or ceritinib, on previously untreated patients with advanced anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer.

Patients treated with Zykadia showed a significant improvement in their chances of surviving without the cancer spreading compared with standard chemotherapy, the firm said.

"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," said Alessandro Riva, a global head in Novartis's oncology unit.

In May, Roche released study results showing its Alecensa drug demonstrated a 66 percent reduction in risk of progression of ALK+ non-small cell lung cancer compared with Pfizer's crizotinib that is now the standard initial treatment for the disease.

Consequently, Alecensa may already have an advantage over Zykadia in taking market share from Pfizer if both drugs win regulatory approval for first-line treatment.

One analyst faulted the Novartis study for comparing the results of its drug with chemotherapy rather than testing its performance against Pfizer's crizotinib.

"It's better to design something against the standard of care," Stefan Schneider, an analyst at Bank Vontobel, told Reuters. "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."

Schneider said in a separate note to investors that the bank believed revenue potential for Novartis's drug as a first-line treatment was "limited."

Roche plans to release more Alecensa data this year, a spokeswoman said.

Zykadia and Alecensa already have U.S. approval to be used as an alternative or second-line treatment in patients who did not tolerate Pfizer's crizotinib, whose brand name is Xalkori.

Zykadia also has the green light for second-line treatment in Europe.

Some analysts have trimmed forecasts for Zykadia in recent months to $320 million in sales in 2020, according to an average of estimates collected by Thomson Reuters.

Alecensa is seen bringing in about 680 million Swiss francs ($700 million) in 2020, the data shows.

ALK+ non-small cell lung cancer affects between 2 and 7 percent of roughly 1.8 million new lung cancer cases reported annually.