Novartis hands off buparlisib to China's Adlai Noryte

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A paper published last December in The Lancet Oncology "does not support" the further development of a buparlisib-fulvestrant combination for patients with HR-positive, HER2-negative breast cancer. (rawpixel)

Adlai Noryte grabbed worldwide rights to Novartis' buparlisib, an oral PI3K inhibitor being developed for blood cancers and solid tumors that has run into toxicity issues. 

Except for "certain rights" maintained by Novartis, Adlai Noryte has exclusive development and commercialization rights to buparlisib for therapeutic, prophylactic and/or diagnostic use in humans, the company said in a statement. 

"Buparlisib has been extensively profiled in breast cancer and other tumor types. Buparlisib when combined with other therapies has shown impressive anti-cancer efficacy in [head and neck squamous cell carcinoma]," said Adlai Noryte CEO Carsten Lu in the statement. "It has very good market prospects when combined with paclitaxel, and we are planning to carry out clinical trials of combination of buparlisib and immune check point inhibitor treatment." 

While Adlai Noryte is painting a rosy picture for buparlisib, a paper published last December in The Lancet Oncology "does not support" its further development. The study tested buparlisib in combination with fulvestrant in patients with HR-positive, HER2-negative breast cancer that progressed even after treatment with endocrine therapy and mTOR inhibitors. 

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This safety profile is unsurprising in a field dogged with safety issues. Gilead's Zydelig, approved in 2017 for three types of blood cancers, is indicated for use in combination with Rituxan, or in patients who have already failed two other therapies. Safety issues hamstrung Gilead's efforts to get the drug approved as a first-line therapy. 

While the median progression-free survival in the buparlisib arm was "significantly longer" than in the group that received placebo, about one-fifth of the buparlisib patients experienced serious adverse events, including aspartate aminotransferase, dyspnoea and pleural effusion. Of the grade 3-4 adverse events observed, the most common were elevated alanine aminotransferase (22% versus 3% in the placebo group) and elevated aspartate aminotransferase (18% versus 3%).

The treatment group also experienced higher rates of hypertension and fatigue than the control group did, but these rates were closer together—6% versus 4% and 3% versus 1%, respectively. 

While the safety profile is troubling, the study authors did say that buparlisib's efficacy suggests that PI3K inhibitors might be effective alongside endocrine therapy in patients with PIK3CA mutations. 

Novartis isn't the only company to hand off the rights to a PI3K inhibitor. Roche out-licensed its PI3K drug to Australia's Novogen in 2016 and Eli Lilly started seeking partners in July 2017 for several midphase oncology programs, including a PI3K/mTOR dual inhibitor. And it didn't stop there—just last month, Roche ditched its PI3K hopeful, taselisib, after it put up "modest" efficacy data and a risk of "considerable side effects." 

The news comes a week after Adlai Noryte raised $53 million in its series B. The Hangzhou, China-based biotech's lead asset is an oncolytic virus dubbed Reolysin, which is poised to enter phase 3 in breast cancer. It is also working on an oral EP4 antagonist for solid tumors and an IDO inhibitor for "various tumor types."