Findings from the phase 3 CONTACT-01 trial indicated that cabozantinib and atezolizumab did not reach the primary end point of overall survival in patients with metastatic non–small cell lung cancer.
Cabozantinib (Cabometyx) and atezolizumab (Tecentriq) combination therapy did not meet the primary end point of overall survival (OS) in the phase 3 CONTACT-01 study (NCT04471428) for patients with metastatic non–small cell lung cancer (NSCLC) but demonstrated no new safety signals, according to a press release on the study’s final analysis of data.
The safety profile of cabozantinib plus atezolizumab was consistent with those reported in previous studies for each agent. Investigators of CONTACT-01 will submit detailed findings from the study for presentation at a future medical meeting.
“The results from the CONTACT-01 clinical trial have shown the challenge of treating patients [with NSCLC] after prior lines of treatment have failed,” Howard Mayer, MD, executive vice president and head of Research and Development at Ipsen, said in the press release. “While the findings of the study have not met the primary end point in this setting, we remain confident in the clinical efficacy of cabozantinib alone and in combination with another treatment in existing indications in difficult-to-treat tumor types.”
Investigators of the global, multicenter, randomized phase 3 CONTACT-01 study enrolled a total of 366 patients with squamous or non-squamous metastatic NSCLC that has progressed during or following anti–PD-1/PD-L1 therapy received concurrently or sequentially with chemotherapy. Patients were randomly assigned 1:1 to either receive 1200 mg of atezolizumab intravenously on day 1 of each 21-day cycle with 40 mg of cabozantinib taken orally once a day on days 1 to 21 of each cycle, or 75 mg/m2 of docetaxel intravenously on day 1 of each 21-day cycle.
Key secondary end points for the CONTACT-01 study included progression-free survival, objective response rate, duration of response, and safety.
Patients 18 years and older who had a histologically or cytologically confirmed diagnosis of metastatic NSCLC and documented radiographic disease progression during or following treatment with platinum-containing chemotherapy and anti–PD-L1/PD-1 antibodies were eligible to enroll on the study. Additional inclusion criteria included having measurable disease per RECIST v1.1 guidelines, a known PD-L1 status or availability of tumor tissue for central PD-L1 testing, an ECOG performance status of 0 or 1, adequate hematologic and organ function, a negative human immunodeficiency virus test at screening, and a negative hepatitis B surface antigen test at screening.
Patients were unable to enroll on the study if they had received prior therapy with cabozantinib, docetaxel, or anti–PD-L1/PD-1 antibodies for NSCLC or any treatment with investigational therapies within 28 days before beginning study treatment. Patients were also unsuitable for enrollment if they had symptomatic, untreated, or actively progressing central nervous system metastases; a history of leptomeningeal disease; uncontrolled tumor-related pain; a severe hepatic impairment; uncontrolled or symptomatic hypercalcemia; or any other active malignancy at the time of beginning study treatment or diagnosis of another malignancy within 3 years prior to initiation of study treatment that requires active treatment.
Ipsen provides update on phase III CONTACT-01 trial evaluating cabozantinib in combination with atezolizumab in patients with metastatic non-small cell lung cancer previously treated with immunotherapy and chemotherapy. News release. Ipsen. December 8, 2022. Accessed December 12, 2022. bit.ly/3j1z1pO