Rami Manochakian, MD, on NSCLC: Clinical Implications of Findings on Nivolumab Plus Chemotherapy
2022 ASCO Annual Meeting
Rami Manochakian, MD, of Mayo Clinic Florida, discusses the phase II findings of the NADIM II trial, which confirmed that, in terms of pathologic complete response as well as the feasibility of surgery, combining nivolumab and chemotherapy was superior to chemotherapy alone as a neoadjuvant treatment for locally advanced, resectable stage IIIA non–small cell lung cancer (Abstract 8501).
Disclaimer: This video transcript has not been proofread or edited and may contain errors.
The NADIM II Trial is a randomized open label Phase II trial of Neoadjuvant Nivolumab with a regimen, chemotherapy regimen, of carboplatin paclitaxel versus chemotherapy alone, given in three cycles for patients with Stage 3A non-small cell lung cancer. After the three cycle of the neoadjuvant therapy, patient proceeded with surgery, and following surgery, patient received six months of Adjuvant Nivolumab. This study was done by the Spanish Lung Cancer Group Trial. The study primary endpoint was the pathological complete response rate, and secondary endpoint, there was the major pathological response rate, as well as response rate and also adverse events. This study is important, since it's really looking in particular at the Stage 3A patients with non-small cell lung cancer. This is a challenging population.
There is an evolving research and trials testing in particularly this population. We have recently reported CheckMate 816, that led to the approval of Neoadjuvant Nivolumab and chemotherapy in patients from Stage 1B to Stage 3. We have the Adjuvant therapy also approved in a patient with Stage 3. We have the patient who don't undergo resection, and they receive concurrent chemoradiation. So, what this trial is come as a validation to the CheckMate 816, looking in particularly to this patient of a Stage 3A.
The result of the studies were positive. The primary endpoint, which was the pathological complete response rate, was about 36% versus 7% in the patients who did not get the immunotherapy and received the chemotherapy alone. The secondary endpoint, the major pathological response rate, which means the 10% or less of viable tumor in the resected specimen and lymph node, was 52% versus 13%. The overall response rate was 74% versus 48%. And the adverse event, there was some modest increase in the adverse event, in particularly the Grade 3, 4. It was about 24% versus 20%.
This study is, again, comes as a validation for the role of Neoadjuvant chemotherapy and immunotherapy in patient with Stage 3A. This is something that has continued to evolve, as I mentioned earlier, and it's definitely set a standard of care option as one of the option for patients who potentially have resectable Stage 3 non-small cell lung cancer to receive chemotherapy and immunotherapy, followed by surgery and followed by Adjuvant immunotherapy.
Clifford A. Hudis, MD, of the American Society of Clinical Oncology, and Karen E. Knudsen, PhD, MBA, of the American Cancer Society, discuss their collaboration, pooling their research and education resources to help empower patients with cancer and their families. Within 48 hours, Drs. Hudis and Knudsen were able to gear up a rapid response to the crisis in Ukraine, forming a clinical corps of volunteers to post information online in multiple languages, which helped patients navigate their care in the war-torn region. To date, 300 European cancer organizations have joined their efforts.
Sue S. Yom, MD, PhD, of the University of California, San Francisco, discusses a translational analysis from the NRG-HN002 study. This phase II trial established the feasibility of the tumor tissue–modified viral (TTMV) human papillomavirus DNA assay in clinical trial specimens. The goal is to use such an assay to measure tumor volume, levels of TTMV over the course of treatment, and the association of TTMV to treatment outcomes (Abstract 6006).
Jenny S. Guadamuz, PhD, of Flatiron Health, discusses the use of telemedicine services in community oncology clinics for patients initiating treatments for 21 common cancers during the COVID-19 pandemic. Black, uninsured, non-urban, and less affluent patients were less likely to use telemedicine services. Although telemedicine may expand access to specialty care, the proliferation of these services may widen cancer care disparities if equitable access to these services is not ensured, according to Dr. Guadamuz (Abstract 6511).
Sriram Yennu, MD, of The University of Texas MD Anderson Cancer Center, discusses the placebo response in patients with advanced cancer and cancer-related fatigue. His latest findings show that open-labeled placebo was efficacious in reducing cancer-related fatigue and improving quality of life in fatigued patients with advanced cancer at the end of 1 week. The improvement in fatigue was maintained for 4 weeks (Abstract 12006).
Rainer Fietkau, MD, of Germany’s University Hospital Erlangen, discusses phase III findings of the CONKO-007 trial, which examined the role of sequential chemotherapy and chemoradiotherapy administered to patients with nonresectable locally advanced pancreatic cancer following standard-of-care chemotherapy (Abstract 4008).