AbbVie and Nuvalent presented new data from their respective oncology pipelines at the European Society for Medical Oncology (ESMO) Congress 2024, showcasing advancements in antibody-drug conjugates (ADCs) and kinase inhibitors for solid tumors. The data highlight potential new treatment options for patients with ovarian cancer, non-small cell lung cancer (NSCLC), and gastroesophageal cancer.
AbbVie's ADC Pipeline Shows Promise
AbbVie presented full data from the Phase 2 PICCOLO trial of mirvetuximab soravtansine (ELAHERE®) in patients with high folate receptor-alpha (FRα) expressing platinum-sensitive ovarian cancer (PSOC). The trial met its primary endpoint, demonstrating an objective response rate (ORR) of 51.9% (95% CI: 40.4, 63.3) in heavily pre-treated patients. The median duration of response (DOR) was 8.3 months (95% CI: 5.5, 10.8), and median progression-free survival (PFS) was 6.9 months (95% CI: 5.9, 9.6). The safety profile was consistent with previous studies.
"There is an urgent patient-driven unmet need to identify novel, effective and tolerable therapies for patients with platinum-sensitive ovarian cancer, including the PARPi pre-treated setting where diminished response to subsequent platinum-based chemotherapy has been reported," said Angeles Alvarez Secord, M.D., M.H.Sc., from the Duke Cancer Institute.
AbbVie is also advancing telisotuzumab vedotin (Teliso-V), a c-Met directed ADC, for advanced NSCLC. The company plans to submit Teliso-V for accelerated approval as a monotherapy in patients with previously treated c-Met overexpressing, epidermal growth factor receptor (EGFR) wild-type non-squamous NSCLC in Q3 2024. The FDA granted breakthrough therapy designation for Teliso-V in 2022, with an approval decision anticipated in 2025.
Additionally, new data from a Phase 1 study of telisotuzumab adizutecan (ABBV-400), a next-generation c-Met directed ADC, were presented. In NSCLC patients, ABBV-400 demonstrated an ORR of 43.8% and a clinical benefit rate of 85.4%. In gastroesophageal cancer (GEA) patients, the ORR was 28.6%, and the clinical benefit rate was 71.4%.
Nuvalent's Kinase Inhibitors Demonstrate Durability
Nuvalent presented updated Phase 1 data from its ALKOVE-1 and ARROS-1 clinical trials at ESMO 2024. The ALKOVE-1 trial is evaluating NVL-655, an ALK-selective inhibitor, while the ARROS-1 trial is assessing zidesamtinib, a ROS1-selective inhibitor. Both trials showed promising results in heavily pre-treated patient populations.
In the ALKOVE-1 trial, 133 patients received NVL-655. In the ARROS-1 trial, 104 patients received zidesamtinib. The data presented at ESMO 2024 also included information on the investigational drugs' ability to manage CNS metastases, a common complication in advanced cancer cases.
Christopher Turner, M.D., Chief Medical Officer at Nuvalent, expressed confidence in the potential of these therapies to provide deep and durable responses by addressing treatment-emergent resistance, brain metastases, and off-target central nervous system (CNS) adverse events.
Nuvalent plans to initiate the ALKAZAR Phase 3 trial in the first half of 2025. This trial will evaluate NVL-655 versus alectinib in TKI-naïve ALK-positive NSCLC patients. The company expects to report pivotal data from the Phase 2 ARROS-1 and ALKOVE-1 trials in 2025.
