Nuvation Bio to present pooled ROS1 lung cancer data to FDA

Nuvation Bio recently showcased pooled data from its two Phase 2 clinical trials at the annual European Society for Medical Oncology (ESMO) conference in Barcelona. The company plans to submit this data to the FDA in the near future. The trials, conducted separately in China and Western countries, demonstrated notable results with the company’s oral drug taletrectinib, taken once daily. Impressively, 89% of the patients across these studies experienced tumor reduction, as stated by CEO David Hung.

The company aims to leverage these findings in its upcoming FDA submission, bolstered by its acquisition of AnHeart Therapeutics. A total of 337 patients with ROS1-positive non-small cell lung cancer (NSCLC) participated in these studies, each receiving 600 mg of taletrectinib in 21-day cycles. The median follow-up period was 21 months, with the data cut-off on June 7.

Further analysis was conducted on 160 patients who had not previously been treated with TKI inhibitors. Tumor shrinkage was observed in 89% of these patients, and 13 out of 17 individuals with measurable brain metastases also saw reductions. The median duration of response stood at 44 months, with a median progression-free survival of 46 months.

Among another group of 113 patients who had previously received TKI inhibitors, 56% experienced tumor reduction. Brain metastases decreased in size in 21 out of 32 patients in this cohort.

Hung emphasized the significance of these patient groups to the FDA due to the aggressive nature of ROS1-positive NSCLC, which is much rarer compared to its ROS1-negative counterpart. Although TKI inhibitors are approved for treating ROS1-positive NSCLC, patients often develop resistance mutations.

"This is a relatively rare type of lung cancer, accounting for about 2% of non-small cell lung cancer cases, but it tends to be quite aggressive," said Hung. He contrasted the median progression-free survival for standard immuno-oncology treatments and chemotherapy for non-small cell lung cancer, which typically ranges from six to eight months.

Following the release of data from the Western study at the World Conference on Lung Cancer, analysts expressed optimism. TD Cowen analyst Yaron Werber noted that the data continues to support the potential of taletrectinib in treating ROS1-positive NSCLC.

If the regulatory process proceeds smoothly, Werber anticipates that Nuvation could launch taletrectinib by the end of 2025. Hung brings a wealth of experience from his previous biotech ventures, notably steering Medivation to a $14 billion acquisition by Pfizer in 2016.