Innovative combination clinical trial results revealed at ASCO
May 31, 2019
Medically Reviewed | Last reviewed by an MD Anderson Cancer Center medical professional on May 31, 2019
MD Anderson researchers will present clinical trial results of promising combination therapies for a variety of cancers at the 2019 American Society of Clinical Oncology (ASCO) annual meeting, which begins Friday in Chicago.
The ASCO session brings together more than 32,000 oncology professionals from around the world to share the latest cancer treatment and oncology research results. Among highlighted findings from hundreds of presentations by MD Anderson clinicians and scientists are:
- Overall survival results for premenopausal patients who receive a targeted therapy with hormonal therapy for hormone-receptor-positive breast cancer.
- Major pathological responses for patients who receive an immunotherapy combination before undergoing surgery for their locally advanced non-small cell lung cancer.
- High response rates for diffuse large b-cell lymphoma patients who receive a targeted therapy combination before going on to chemotherapy.
Details of the breast cancer treatment findings, a massive study led by Debu Tripathy, M.D., chair of Breast Medical Oncology, will be released early Saturday morning at the meeting and will be covered in MD Anderson’s newsroom.
The phase III trial, known as MONALEESA-7 (ASCO abstract LBA1008), compared adding the targeted therapy ribociclib to hormone therapy vs. hormone therapy and a placebo. Ribociclib inhibits cyclin-dependent kinases 4/6 (CDK4/6), proteins vital to cell cycle function.
Ribociclib was approved in 2018 by the Food and Drug Administration for treatment of premenopausal patients with advanced HR+ breast cancer in combination with hormone therapies, based on progression-free survival data from MONALEESA-7.
Pre-surgical immunotherapy for lung cancer
Neoadjuvant treatment with immune checkpoint inhibitors nivolumab and ipilimumab resulted in a major pathologic response in more than 30% of patients with early-stage, resectable lung cancers in the Phase II NEOSTAR trial (Abstract 8504) conducted at MD Anderson.
Major pathologic response is defined as less than 10 percent of viable tumor remaining at surgery.
Trial results indicate the immunotherapy combination merits additional evaluation, says principal investigator Tina Cascone, M.D., Ph.D., assistant professor of Thoracic/Head & Neck Medical Oncology.
About half of people with potentially curable early-stage disease who are treated with surgery alone eventually have recurrence.
The trial enrolled 44 patients, randomized to either nivolumab (anti-PD-1) alone or nivolumab plus ipilimumab (anti-CTLA-4). Six patients (38%) receiving combination therapy achieved a complete response compared to two patients (10%) receiving nivolumab.
The researchers are analyzing data from biospecimens taken before, during and after treatment to guide future research and clinical trials.
Triple-targeted therapy for large B-cell lymphoma
A combination targeted therapy – rituximab, lenalidomide and ibrutinib (RLI) – achieved an 84.6% overall response rate and 38.5% complete response rate when given before chemotherapy for newly diagnosed patients with non-germinal center diffuse large b-cell lymphoma (DLBCL) in a Phase II clinical trial (ASCO Abstract 7508).
Study leader Jason Westin, M.D., assistant professor of Lymphoma & Myeloma., calls the pre-chemotherapy results remarkable. “All patients have gone on to receive standard chemotherapy in combination with these targeted treatments per the protocol, and, so far, we’ve had a 100 percent response rate,” Westin says.
Large-cell lymphomas are diagnosed in approximately 30,000 individuals each year in the U.S. Non-germinal center cases account for an estimated 30-40% of those cases and does not respond as well to standard-of-care chemotherapy.