Dr Das on the ALINA Trial in Early-Stage ALK+ Lung Cancer

Millie Das, MD, member, Stanford Cancer Institute; clinical professor, Department of Medicine, Med/Oncology, Stanford Healthcare, discusses 3 key clinical trials that have advanced treatment for patients who present with non–small cell lung cancer (NSCLC).

The first of these 3 studies is the phase 3 ALINA trial (NCT03456076), which investigated adjuvant alectinib (Alecensa) in early-stage resected ALK-positive lung cancer, Das begins. The trial demonstrated a significant disease-free survival benefit with alectinib compared with chemotherapy, leading to its FDA approval in April 2024, she says. Das adds that this approval provided an effective new treatment option for eligible patients.

Data from the phase 3 LAURA trial (NCT03521154) were presented during the plenary session at the 2024 ASCO Annual Meeting, Das continues, noting that the presentation received a standing ovation at the conference. Patients with unresectable stage III EGFR-mutant lung cancer who had undergone chemoradiation were randomly assigned to receive either osimertinib (Tagrisso) orplacebo, she reports. The results showed a significant benefit for those receiving osimertinib, leading to widespread anticipation of its approval for patients with EGFR-mutant lung cancer following chemoradiation, Das says. Although not yet approved, a supplemental new drug application seeking the approval of osimertinib was granted FDA priority review for this indication in June, 2024.

However, data with neoadjuvant osimertinib remains limited, Das states. In a multi-institutional trial (NCT03433469) of 27 patients with surgically resectable stage I-IIA EGFR-mutant NSCLC, osimertinib did not achieve the desired major pathologic response rate, with only a 15% response rate observed in the intention-to-treat analysis, Das reports. Patients enrolled onto this trial received osimertinib 1 to 2 months prior to surgery. This lower-than-expected response rate highlights the need for further research, she states.

There is growing interest in combining osimertinib with chemotherapy in the neoadjuvant setting, an approach being explored in the ongoing phase 3 NeoAdora trial (NCT04351555), Das adds. This combination aims to improve outcomes and provide more effective treatment strategies for patients with EGFR-mutant lung cancer, Das concludes.