News Release 

Pre-surgical immunotherapy shows promise in trial for patients with early stage lung cancer

Interim results of a large, multicenter trial to be presented at ASCO Annual Meeting

Dana-Farber Cancer Institute

For patients with operable non-small cell lung cancer (NSCLC), pre-surgical "neoadjuvant" treatment with an immune checkpoint inhibitor was well tolerated and, in many cases, caused significant tumor cell death in a large, multicenter clinical trial involving investigators at Dana-Farber Cancer Institute, Brigham and Women's Hospital, and nine other research centers. Interim results of the trial will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting.

Participants in the trial had surgically removable NSCLC ranging from stage IB to IIIB. Patients were treated with two cycles of atezolizumab, which blocks the PD-L1 immune checkpoint protein on some cancer cells, then had surgery to remove the lung cancer tissue.

The results to be reported today involve the first 101 participants in the trial, 90 of whom had surgery following treatment with atezolizumab. Excluding eight patients whose cancers had driver mutations, 15 participants (representing 18% of the total) had a major pathologic response to the treatment, defined as 10% or fewer viable cancer cells detected in the surgically removed tumor tissue. Four patients had a pathological complete response, an absence of residual cancer following the neoadjuvant therapy. Seventy-two of the participants had stable disease, and four had their disease progress.

Treatment related adverse events rated as Grade 3 or 4 - considered severe or urgent - occurred in six of the 90 participants.

"Immune checkpoint therapy is included as a standard of care for patients with advanced (metastatic) lung cancer, and this study suggests that it may also have benefit in early stage, operable lung cancer," said the study's lead author, David Kwiatkowski, MD, PhD, senior physician at Dana-Farber/Brigham and Women's Cancer Center.

Researchers will present Abstract #8503 at the Lung Cancer--Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers session on Saturday, June 1 at 2:15 p.m. CT in Hall D2 of the McCormick Place.

The senior author of the study is David P. Carbone, MD, PhD, of Ohio State University. Co-authors are Valerie Rusch, MD, and Jamie Chaft, MD, of Memorial Sloan Kettering Cancer Center; Bruce Johnson, MD, of Dana-Farber; Alan Nicholas, PhD, See Phan, MD, Katja Schulze, PhD, and Ann Johnson, MBA, of Genentech Inc.; Ignacio Wistuba, MD, of MD Anderson Cancer Center; Robert Merritt, MD, of Ohio State University; Jay M Lee, MD, of UCLA David Geffen School of Medicine; Paul Bunn, MD, of the University of Colorado; Yan Tang, PhD, of Brigham and Women's; Saiama N Waqar, MD, and Alexander Patterson, MD, of Washington University School of Medicine; Eric Haura, MD, and Eric M. Toloza, MD, of H. Lee Moffitt Cancer Center; and Karen L Reckamp, MD, and Dan Raz, MD, of City of Hope Comprehensive Cancer Center. Supported by Genentech, Inc. and the Lung Cancer Research Foundation.

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