Nuvalent, Inc. (NUVL) made headlines over the weekend at the European Society for Medical Oncology (ESMO) Congress 2024, presenting updated data from its ongoing Phase 1/2 trials of zidesamtinib (ARROS-1) and NVL-655 (ALKOVE-1). These trials are investigating the potential of these drugs to treat patients with advanced ROS1-positive and ALK-positive non-small cell lung cancer (NSCLC) and other solid tumors.
The ARROS-1 trial, evaluating zidesamtinib in 227 patients with TKI-naïve and TKI-pretreated advanced ROS1-positive NSCLC and other solid tumors, showed particularly encouraging results. In the overall patient population, the objective response rate (ORR) was a significant 44%, with a duration of response (DOR) exceeding six months for 83% and exceeding 12 months for 67%. The median duration of response (mDOR) is yet to be reached. The data also highlighted the effectiveness of zidesamtinib in patients with confirmed ROS1 G2032R resistance mutation, with an impressive ORR of 72% (13/18) for repotrectinib-naïve patients.
In the ALKOVE-1 trial, focusing on NVL-655 in 229 patients with TKI-naïve and TKI-pretreated advanced ALK-positive NSCLC and other solid tumors, the company also presented promising findings. The overall ORR at the recommended Phase 2 dose (RP2D) and across all doses was 38%, with a DOR exceeding six months for 78% of patients at all doses and 100% for those receiving RP2D. The mDOR for RP2D is yet to be reached, while the mDOR for all doses reached 14.4 months.
Nuvalent is optimistic about the potential of both zidesamtinib and NVL-655 to provide deep and durable responses, particularly in the front-line setting. The company plans to initiate a Phase 3 study, ALKAZAR, with registrational intent for TKI-naïve patients with ALK-positive NSCLC in the first half of 2025. This significant step indicates Nuvalent’s commitment to bringing these promising therapies to patients with these challenging cancers.
The positive data presented at ESMO Congress 2024 has boosted investor confidence in Nuvalent, resulting in a significant 22.6% increase in NUVL stock price on Monday. With the upcoming Phase 3 study and anticipated pivotal data from both trials in 2025, Nuvalent is poised to play a crucial role in shaping the future of cancer treatment.
