New antibody drug combination to treat patients with advanced lung cancer fast-tracked by FDA
Clinical trial investigations of a targeted therapy called sacituzumab govitecan demonstrated promising anti-tumor activity in patients with hard-to-treat, metastatic lung cancer, according to results presented by Michael J. Guarino, M.D., a medical oncologist at Christiana Care’s Helen F. Graham Cancer Center & Research Institute, during the 2015 Annual Meeting of the American Society of Clinical Oncology, held May 29 to June 2, in Chicago.
Sacituzumab govitecan is a first-in-class antibody drug conjugate that combines a chemotherapy drug (SN-38) with a humanized antibody designed in the lab to target the Trop-2 receptor expressed by many solid cancers. SN-38 is the active metabolite of irinotecan (Camptosar) used to treat solid tumors, particularly metastatic colorectal cancer. This knock-out combination is capable of delivering 136 times more SN-38 than its parental drug directly to the tumor and thus minimizing harm to surrounding healthy tissue.
Lung cancer is the second most commonly diagnosed cancer in the U.S. and the deadliest, killing more people than breast, colon and prostate cancers combined. The two types of lung cancer are small cell (SCLC) and non-small cell (NSCLC), which is the most common.
Patients with advanced stage NSCLC are commonly treated with chemotherapy, targeted drugs or some combination of the two. For SCLC, which is the more aggressive lung cancer, treatment is limited to chemotherapy with or without radiation therapy. Five-year survival rates for both types of lung cancer are very low (2.7 percent to 3.7 percent).
In a multicenter study of 47 patients with metastatic lung cancer (25 NSCLC, 22 (SCLC), treatment with sacituzumab govitecan produced tumor shrinkage of 30 percent or more in patients with NSCLC (32 percent) and SCLC (30 percent). For the 25 patients who responded to the study drug, all 11 SCLC patients and 12 of 14 NSCLC patients, or 86 percent, had a time-to-disease progression that was longer than their last therapy. These patients had previously failed a median of 2.5 (range 1-7) and 3 (range 1-8) cancer treatments, respectively. The study also showed that these heavily pre-treated lung cancer patients safely tolerated the drug.
“This is an interesting and unique delivery system of an effective third- or fourth-line cancer treatment with relatively low toxicity for lung cancer, a disease that is very difficult to treat,” Dr. Guarino explained. “The duration of response to this drug offers a glimmer of hope for patients that they can feel better and live longer, even after trying other conventional therapies unsuccessfully. The study also holds promise that further testing of this drug could reveal additional benefit to patients.”
Following the Phase 2 trial, the FDA has fast-tracked development and review of sacituzumab govitecan for the treatment of NSCLC in patients who have failed two prior lines of therapy. The drug is already fast-tracked to treat SCLC and triple negative breast cancer.
Recognized nationally as a leader in U.S. clinical trial enrollment, Christiana Care was a top recruiter in this study. Medical Oncologist Gregory A. Masters, M.D., also at the Helen F. Graham Cancer Center & Research Institute, participated as a co-investigator in the study. Other principal investigators included Alexander N. Starodub, Indiana University Health Center for Cancer Care, Goshen, IN; Rebecca Heist and Aditya Bardia, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA; Wells A. Messersmith, University of Colorado Cancer Center, Aurora, CO; Allyson J. Ocean, Weill Cornell Medical College, New York, NY; and Sajeve S. Thomas, UF Health Cancer Center, Orlando, FL.
About Christiana Care Health System
Christiana Care Health System is one of the country’s largest health care systems, ranking as the 22nd leading hospital in the nation and 12th on the East Coast in terms of admissions. The health system includes The Christiana Care Medical Group, a network of primary care physicians, medical and surgical specialists as well as home health care, preventive medicine, rehabilitation services and patient/family advisors for core health care services. A not-for-profit teaching hospital affiliated with Sidney Kimmel Medical College at Thomas Jefferson University, Christiana Care is recognized as a regional center for excellence in cardiology, cancer and women’s health services. Christiana Care has an extensive range of outpatient services, and through Christiana Care Quality Partners, Christiana Care works closely with its medical staff to achieve better health, better access to care and lower cost. Christiana Care is home to Delaware’s only Level I trauma center, the highest capability center and the only one of its kind between Philadelphia and Baltimore. Christiana Care also features a Level III neonatal intensive care unit, the only delivering hospital in Delaware that offers the highest level of non-surgical care to the most critically ill newborns. Christiana Care includes two hospitals with 1,100 patient beds. For more information about Christiana Care, visit www.christianacare.org/whoweare.
Barbara Jacoby is an award winning blogger that has contributed her writings to multiple online publications that have touched readers worldwide.