Nuvation Bio outlined pooled data from its two Phase 2 studies at the annual European Society for Medical Oncology confab in Barcelona this weekend as it prepares to approach the FDA soon.
The company said that across the two trials — one conducted in China, the other in Western countries — 89% of patients saw their tumors shrink after taking its once-daily oral drug taletrectinib. Separate datasets from both Phase 2 studies, as well as the pooled ESMO analysis, are expected to form the backbone of Nuvation’s FDA submission, CEO David Hung told Endpoints News.
With the data, Nuvation is aiming to capitalize on its all-stock deal for AnHeart Therapeutics from March.
Nuvation enrolled 337 patients who had ROS1-positive non-small cell lung cancer in both studies, and individuals took 600 mg of the drug in 21-day cycles. The median follow-up was 21 months, and the cut-off date was June 7.
Researchers also took a closer look at 160 patients who hadn’t yet received TKI inhibitors in the studies. Nuvation said tumors shrank in 89% of these individuals, and measurable brain metastases shrank in 13 of 17 people. The median duration of response was 44 months and median progression-free survival was 46 months, Nuvation said.
Additionally, 56% of 113 patients who had previously received a TKI inhibitor also saw their tumors shrink. The brain metastases shrank in 21 of 32 patients as well.
David HungHung said that these groups of patients are important to the FDA because ROS1-positive NSCLC is much rarer and more aggressive than ROS1-negative NSCLC. TKI inhibitors are approved to treat the ROS1-positive form, but many patients end up developing resistance mutations to them.
“This is a relatively rare type of lung cancer. It’s about 2% of non-small cell lung cancer, but it tends to be quite aggressive,” Hung said. “If you look at the standard of care for non-small lung cancer in immuno-oncology agents and chemotherapy, the median progression-free survival is generally about six to eight months.”
Analysts also viewed the data positively after the Western study data were published at the World Conference on Lung Cancer annual meeting earlier this week. TD Cowen analyst Yaron Werber wrote that the WCLC data “continue to support taletrectinib’s promise” in ROS1-positive NSCLC.
If everything goes according to plan, Werber expects Nuvation could launch taletrectinib by the end of 2025.
Hung is also experienced in running biotechs attractive to large pharma M&A teams — in 2016, Pfizer acquired Hung’s last biotech, Medivation, for $14 billion.