Turning Point Therapeutics Inc. (NASDAQ: TPTX) shares dipped on Friday after the firm posted interim data for its midstage study in ROS1-positive non-small cell lung cancer patients. The data came from the firm’s ongoing Phase 1/2 Trident-1 clinical study of repotrectinib.
The results are being presented at the annual meeting of the American Society of Clinical Oncology (ASCO). They demonstrate ongoing antitumor activity and a manageable safety profile across multiple dose cohorts in both tyrosine kinase inhibitor (TKI) naïve and TKI-pretreated patients, including patients with intracranial disease.
A total of 83 patients were treated with repotrectinib at two different dose levels, and it was generally well tolerated. The most frequent treatment emergent adverse events (Grade 1 or 2) seen in patients were: dizziness (57%), dysgeusia (51%), dyspnea (30%), fatigue (30%), constipation (29%), paresthesia (29%) and anemia (28%). There were few Grade 3 treatment-related adverse events: (anemia (n=3); dizziness (n=2); and dyspnea, hypophosphatemia, hypoxia, pleural effusion and weight increase (all n=1), and no Grade 4 treatment-related adverse events or cases of dizziness leading to treatment discontinuation.
Out of the total 83 patients, the preliminary efficacy analysis is for 33 patients. Forty-five percent of patients remained on treatment (15/33), with 12 of the 15 (80%) patients remaining on treatment for more than 12 months.
Dr. Byoung Chul Cho, Yonsei Cancer Center at Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea, commented:
With additional follow up and new patients enrolled in the TRIDENT-1 study, repotrectinib continues to demonstrate promising efficacy and a safety profile consistent with a potential best-in-class ROS1 therapy for patients with advanced non-small cell lung cancer. The ongoing Phase 1 data remain encouraging in both TKI-naïve patients with intracranial disease and patients pretreated with crizotinib — including those with difficult to treat solvent front mutations — where there are currently very few therapeutic options.
Shares of Turning Point were down about 15% at $33.10 on Friday, in a 52-week range of $24.21 to $41.93. The consensus price target is $50.33.
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