Lung Cancer Immunotherapy Trial Proves Efficacy

McGill University Health Centre (MUHC), Centre hospitalier de l’Université de Montréal (CHUM), and St. Mary’s Hospital Center (SMHC) have collaborated on an international clinical trial that will change the way we treat non-small cell lung cancer (NSCLC), the most common type of lung cancer.

In this trial, an immunotherapy drug called pembrolizumab (KEYTRUDA) was shown to slow cancer progression and recurrence and to reduce the presence of residual tumors in patients with early-stage operable NSCLC when used in conjunction with neoadjuvant chemotherapy (i.e., given before surgery) and then again after surgery. Three out of five patients in the experimental group stayed stable for two years (without cancer progression or recurrence), compared to two out of five in the control group, representing a 50 percent improvement.

This randomized, double-blind, Phase III clinical trial’s interim analysis was just presented at the American Society of Clinical Oncology (ASCO) 2023 Annual Meeting in Chicago and published in The New England Journal of Medicine.

“It’s an honor for me to bring the most promising lung cancer therapies to our patients by playing a leading role in the conduct of international randomized clinical trials,” says Dr. Jonathan Spicer, senior author and lead surgeon of the study, medical director of the McGill Thoracic Oncology Network, scientist in the Cancer Research Program at the Research Institute of the McGill University Health Centre (RI-MUHC) and thoracic surgeon at the Montreal General Hospital of the MUHC.

“This new treatment is another important step towards improved outcomes for patients with this common type of lung cancer. It is applicable to all patients with stage II or III NSCLC who are eligible for surgery. This represents a large number of patients on an annual basis for whom improvement in survival will be very significant.”

Enhancing Cancer Survival
All participants in the trial had stage II or III non-small cell lung carcinoma that was surgically removed. Previously, these stages were connected with a less than 50% survival rate five years following diagnosis. Half were given neoadjuvant pembrolizumab plus cisplatin-based chemotherapy, followed by surgical resection and adjuvant pembrolizumab, while the other half were given neoadjuvant chemotherapy and surgery alone, with a placebo instead of pembrolizumab.

The researchers tracked the occurrence of unwanted events such as local tumor growth that prevented the planned surgery, cancer recurrence, or death in the 24 months following the individuals’ enrolment in one of the two trial groups.

344 (43.2 percent) of the 797 adult participants had an event or died; the majority of the occurrences were illness progression or recurrence. At 24 months, the pembrolizumab group had a 62.4 percent event-free survival rate, while the placebo group had a 40.6 percent event-free survival rate.

The trial’s investigators also assessed the treatment’s effectiveness in lowering tumor size. A major pathological response (less than or equal to 10% residual viable tumors) occurred in 30.2 percent of the pembrolizumab group and 11.0 percent of the placebo group, respectively, and a pathological complete response (absence of residual viable tumors) occurred in 18.1 percent and 4.0 percent.

The neoadjuvant pembrolizumab had no effect on the surgical approach, ability to undergo surgery, or the occurrence of surgical complications. Adverse effects associated with the inclusion of pembrolizumab were consistent with earlier reports from similar immunotherapy and surgical trials.

Montreal is a thoracic oncology innovation hotspot.
The MUHC, CHUM, and SMHC recruited 46 patients in the Montreal area, an exceptional achievement given that the trial was accessible in 227 locations globally. The SMHC was the first center in Quebec to launch the study, setting the path for other facilities, and patients enrolled at the SMHC were treated at the MUHC. The CHUM was the center that recruited the most patients worldwide.

“The CHUM and its research center are extremely proud to have recruited the largest number of patients of any site in this international study. The CHUM Multidisciplinary Thoracic Oncology Research and Clinical Teams work in concert to provide patients from all over the province of Quebec the latest innovations, technologies and therapies in lung cancer care. The future of lung cancer treatment is extremely bright and we will not stop investigating novel therapies until we can offer 100 percent survival to all patients,” says Dr. Moishe Liberman, principal scientist and thoracic surgeon at the CHUM.

“The combination of pembrolizumab with neoadjuvant chemotherapy showed a significantly improved survival rate in treated patients. This is a message of hope for NSCLC patients,” adds Dr. Adrian Langleben, who led the trial at SMHC.

This excellent collaboration elevates Montreal to the forefront of randomized clinical trials in thoracic oncology.

“This work represents a major accomplishment, not only for our extremely collaborative teams in thoracic oncology, but also for our clinical trials unit at the Centre for Innovative Medicine—a fully equipped ‘research hospital within a hospital’ offering access to specialized staff and a full range of services for clinical research,” says Penny Chipman, manager of Oncology Research at the Centre for Innovative Medicine of the RI-MUHC.

“Relying on cross-site collaboration is key to reaching as many patients as possible, and we hope to further develop strategies and partnerships to bring these trials to patients living outside of Montreal and major urban centers,” says Dr. Spicer, who is also an associate professor of surgery at McGill University and an internationally renowned expert on novel therapies for patients with resectable lung cancer.

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