Nuvation Bio showcased longer-term Phase 2 data around the next-gen ROS1 inhibitor it hopes will give Pfizer and Bristol Myers Squibb a run for their money.
In a study conducted in China, taletrectinib spurred an overall response rate of 91% among advanced and metastatic non-small cell lung cancer patients with the ROS1 mutation who have never taken a tyrosine kinase inhibitor (TKI), out to a median follow-up of 23.5 months. In a smaller group of patients pretreated with a TKI, the overall response rate was 52% at a median follow-up of 9.7 months.
Taletrectinib is currently the most advanced asset at Nuvation, which has operations in the US and China. If approved, it would become the company’s first commercial drug — and one with “blockbuster global sales potential,” according to Jefferies. Thursday’s data were released ahead of the American Society of Clinical Oncology meeting next week.
Researchers are also reporting 24-month progression-free survival of 71% for TKI-naïve patients, but only 18% for TKI-pretreated patients.
The most common side effects were liver enzyme elevations and diarrhea, occurring in at least 70% of patients, while a smaller portion of patients experienced dizziness (23%) and alterations in taste (10%).
Led by former Medivation CEO David Hung, Nuvation obtained taletrectinib in March through an all-stock acquisition of US-China biotech AnHeart Therapeutics, which previously licensed it from Daiichi Sankyo.
Based on data from the TRUST-I study, AnHeart had already secured priority review in China. The study enrolled 173 patients as of last November, and reached primary completion in December.
Taletrectinib has a breakthrough therapy designation from the FDA, and a similar pivotal Phase 2 study is being run across the US, Europe and Asia, with more data expected later in the year.
About 1% to 2% of lung cancer patients are estimated to have tumors with ROS1 gene alterations. Roche’s Rozlytrek, Pfizer’s Xalkori and Lorbrena, and more recently Bristol Myers’ Augtyro are currently approved to treat this subtype.