- Aileron Therapeutics (NASDAQ:ALRN) announced interim data from its Phase 1b chemoprotection trial of patients with advanced p53-mutated non-small cell lung cancer (NSCLC) undergoing treatment with first-line carboplatin plus pemetrexed with or without immune checkpoint inhibitors.
- ALRN-6924-treated patients could stay on chemotherapy treatment longer, completing 93% of the first four cycles of carboplatin/pemetrexed administered compared to 78% on placebo.
- This imbalance of completed cycles may have introduced a bias against ALRN-6924 on the composite primary endpoint.
- The imbalance increases further when looking at percentages of patients completing six cycles of treatment (79% on ALRN-6924 versus 57% on placebo).
- This is reflected in the progression-free survival, which was 4.6 months in the ALRN-6924 arm versus 3.2 months in the placebo arm.
- ALRN-6924-treated patients demonstrated 56% of cycles free from serious/severe hematologic toxicities and related events compared to 50% on placebo.
- Aileron plans to stop further enrollment in the NSCLC trial and apply key learnings to strengthen the Phase 1b breast cancer trial.
- Additionally, Aileron plans to modify the dosing strategy for the trial and will not further enroll additional patients in the ongoing 0.3 mg/kg and 0.6 mg/kg dose cohorts.
- Price Action: ALRN shares are down 33.60% at $0.27 during the premarket session on the last check Wednesday.
