The study, dubbed CheckMate 9ER, showed that, for advanced kidney cancer, the combination of Opdivo (nivolumab), an immunotherapy drug, and Cabometyx (cabozantinib), an angiogenesis (blood vessel growth) inhibitor, led to improved outcomes compared with the current standard of care treatment, Sutent (sunitinib). The benefits were seen across many types of patients, including those of different ages and genders, with different levels of expression of PD-L1 (a biomarker that indicates how sensitive a tumor is to some immunotherapy drugs), and those in whom the cancer had spread to the bone. “Patients are significantly more likely to live free of disease progression when treated with nivolumab plus cabozantinib versus Sutent,” said study author Toni K. Choueiri, MD, director of The Lank Center for Genitourinary Oncology at the Dana-Farber Cancer Institute in, and a professor of medicine at Harvard Medical School in Boston.
Combination Therapy Offers Obvious Survival Benefits
The study included 651 previously untreated patients who were randomized to receive either the combination of Opdivo and Cabometyx or Sutent. Opdivo plus Cabometyx showed an improved progression-free survival time (time during which the cancer is not progressing) of 16.6 months compared with 8.3 months for Sutent alone. The median duration of response after 18 months of follow-up was 20.2 months for the combination therapy compared with 11.5 months for Sutent. “Patients in the Sutent arm continued to experience decline and patients in the nivolumab plus cabozantinib group experienced improvement,” Dr. Choueiri said. “Beyond improved treatment response, nivolumab plus cabozantinib offered patients better health-related quality of life compared with Sutent.” The study follow-up period was only 18 months, however, and questions remain about how long the patients’ responses may last. Moreover, the combination therapy was associated with significant side effects. More than one-half of the patients in the combination arm of the study required a dose reduction due to side effects. About 3 percent stopped the therapy due to toxicity compared with 9 percent in the Sutent group. Another study presented at ESMO on September 17, for instance, also demonstrated the clear-cut value of using a combination of medications for kidney cancer. Researchers found the combination of Opdivo (nivolumab) plus Yervoy (ipilimumab) in newly diagnosed patients with advanced kidney cancer was superior to Sutent (sunitinib). In this trial, known as CheckMate-214, the median overall survival rate for the combination was 48.1 months compared with 38.4 months for Sutent. More than one-half of the patients treated with the combination were alive at four years. Both studies add to a growing list of treatment options for people with advanced kidney cancer, said Dominik Berthold, MD, of the Centre Hospitalier Universitaire Vaudois in Lausanne, Switzerland. Dr. Berthold was not involved in either study. “All of this is pretty impressive,” he said. “Physicians will have choices.” RELATED: Cancer News Digest: The Latest Developments in Cancer Research and Treatment for June 2020
In Other News From ESMO
New Approach to Treating Advanced Bladder Cancer
Giving patients with advanced or metastatic urothelial (bladder) cancer the drug Bavencio (avelumab) along with supportive care extended overall survival more than supportive care alone, according to a study published September 18 in The New England Journal of Medicine with release of additional details at ESMO. Bladder cancer is challenging to treat when it spreads beyond the bladder to other parts of the body. Many patients don’t receive any therapy beyond supportive care after receiving chemotherapy, according to the study authors. (Best supportive care is treatment to help the patient with pain or quality-of-life issues.) Bavencio is a type of immunotherapy known as PD-L1 inhibitor. The drug allows the immune system to recognize and mount an immune response to cancer cells. In June, the FDA approved Bavencio for maintenance therapy of patients with advanced or metastatic bladder cancer that had stabilized on chemotherapy. The approval was based on data from the JAVELIN Bladder 100 clinical trial that showed median overall survival with Bavencio was 21.4 months compared with 14.3 months with best supportive care. The new data show that, at one year, 71.3 percent of patients taking Bavencio were alive compared with 58.4 percent of those receiving supportive care. “These data … establish that Bavencio first-line maintenance treatment could fundamentally change clinical practice for the treatment of patients with locally advanced or metastatic urothelial carcinoma,” said coauthor Thomas Powles, MD, professor of genitourinary oncology and lead for solid tumour research at Barts Cancer Institute at Queen Mary University of London, and Director of Barts Cancer Centre in London. RELATED: Blood Cancer Awareness Month: September 2020
Post-Surgical Radiation Is Overkill for Lung Cancer Patients Who’ve Had Surgery and Chemotherapy
Adding radiation after surgery and chemotherapy produces no statistically significant survival benefit in patients with non-small-cell lung cancer (NSCLC), according to data presented September 19 at ESMO. The value of adding post-operative radiation therapy in these patients has been debated for years. The new study, a large, randomized clinical trial, provides more data to help physicians choose the best treatment regimen, said the lead author of the study, Cécile Le Pechoux, MD, a radiation oncologist from Gustave Roussy Institute in Paris. In the trial, 501 patients with stage 2 or stage 3 NSCLC with mediastinal lymph node involvement (cancer in the lymph nodes in the chest) were randomized to receive a five-week course of post-operative radiotherapy (PORT) after chemotherapy or no radiation therapy. The study showed disease-free survival in 47.1 percent of the patients who received post-operative radiation compared with 43.8 percent in those who did not. “Physicians around the world hesitated whether to provide the therapy or not,” said Rafal Dziadziuszko, MD, Medical University of Gdansk in Poland. Dr. Dziadziuszko was not involved in the study. “This is a clear message that routine PORT should not be used in these patients.” RELATED: American Cancer Society Releases New Cervical Cancer Screening Guidelines
