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FDA Approves Immunotherapy Drug for New Indication in Lung Cancer Treatment

The Food and Drug Administration this week approved Keytruda (pembrolizumab) for use in patients with stage II or III non-small cell lung cancer (NSCLC). The immunotherapy can be used in conjunction with chemotherapy before surgery and then on its own after surgery in patients whose cancers are node-positive or whose tumors are 4 centimeters or larger, Healio reported. The approval is based on the results of a phase III clinical trial involving 797 people with stage II or III NSCLC who had not yet received treatment and were eligible for surgery. Participants received chemotherapy and either Keytruda or a placebo before undergoing surgery to remove the tumor. After surgery, participants continued to receive either Keytruda or a placebo. Researchers found the group receiving Keytruda had significantly better overall survival and had a longer median time to progression or recurrence. “This important milestone has the potential to change the current treatment paradigm for resectable non-small cell lung cancer that is greater than 4 centimeters or has lymph node involvement, by offering an immunotherapy-based regimen that has demonstrated statistically significant improvements in overall survival and event-free survival compared [with] a placebo and chemotherapy regimen,” Heather Wakelee, a thoracic medical oncologist at Stanford University Medical Center in California and the trial’s principal investigator, said in a press release.

Study Finds Certain Bladder Cancer Patients Can Avoid Surgery

Results of a phase II clinical trial suggest select patients with muscle-invasive bladder cancer can forgo surgery to remove their bladder with use of chemotherapy and immunotherapy. The current standard treatment for people with muscle-invasive bladder cancer is surgical removal of the bladder, but this procedure comes with significant risk of death and side effects. In the trial, 72 participants received chemotherapy and the immunotherapy drug Opdivo (nivolumab). Researchers found 43% of patients experienced a complete response. While those who did not have a complete response went on to have their bladders removed, 32 of the people who did received additional immunotherapy instead of surgery. Two years later, about 70% of those patients had no evidence of cancer recurrence. “This is the first study to test this specific concept in this manner,” Matthew Galsky, a medical oncologist at Mount Sinai Health System in New York City and the study’s lead author, told OBR Oncology. Experts cautioned that further research is needed to establish which patients will benefit from this treatment but noted the trial’s results are encouraging. “There is a clear wish by patients to keep their bladders as long as they possibly can do so safely,” Arlene O. Siefker-Radtke, a medical oncologist at the University of Texas MD Anderson Cancer Center in Houston who was not involved in the study, told OBR Oncology. “More work is needed to determine how to best select patients for this preservation strategy.”

Women Diagnosed With Lung Cancer at Higher Rates Than Men

Women are being diagnosed with lung cancer at a higher rate than men, and researchers don’t understand what is driving this trend, CNN reported. Lung cancer has traditionally been viewed as a disease that impacts older men because that was the audience primarily targeted by marketing for cigarettes, which are the leading cause of lung cancer. However, in the past 43 years, lung cancer diagnoses have increased 84% in women while they have decreased 36% among men. In a study published last week, researchers found women 35 to 54 were diagnosed with lung cancer at a higher rate than men in the same age group between 2000 and 2019. “When you ask people what the number one cancer killer of women is, most will say that it’s breast cancer. It’s not. It’s lung cancer,” Andrea McKee, a radiation oncologist at the Lahey Hospital & Medical Center Sophia Gordon Cancer Center in Burlington, Massachusetts, and a spokesperson for the American Lung Association, told CNN. “Lung cancer is a women’s health disease, but we clearly need to educate more people about it.” The reason behind this disparity continues to elude researchers. The shift cannot be explained by changes in smoking habits; in fact, non-smoking women have more than double the risk of developing lung cancer compared with male non-smokers. Some researchers and lawmakers are pushing for more funding devoted to research on lung cancer in women. In 2019, the National Institutes of Health spent just 15% of its lung cancer research budget on female-focused studies.