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.
Jonathan E. Rosenberg, MD, of Memorial Sloan Kettering Cancer Center, and Thomas Powles, MD, PhD, of Barts Health NHS Trust, Queen Mary University of London, discuss phase III findings from the KEYNOTE-426 trial, which appear to support the long-term benefit of pembrolizumab plus axitinib for first-line treatment of patients with advanced clear cell renal cell carcinoma (Abstract 4513).
Courtney D. DiNardo, MD, MSCE, of The University of Texas MD Anderson Cancer Center, and Stéphane de Botton, MD, PhD, of Institut Gustave Roussy, discuss phase III findings from the IDHENTIFY trial, which showed that mutational burden and co-mutational profiles differed between patients with relapsed or refractory acute myeloid leukemia that exhibited IDH2-R140 and IDH2-R172 mutations. Enasidenib improved survival outcomes for patients with IDH2-R172 mutations: median overall survival and 1-year survival rates were approximately double those in the conventional care arm (Abstract 7005).
Ruben A. Mesa, MD, of Mays Cancer Center at UT Health San Antonio MD Anderson Cancer Center, discusses new findings from the MOMENTUM study. This trial showed that in symptomatic and anemic patients with myelofibrosis, momelotinib was superior to danazol for symptom and spleen responses, as well as transfusion requirements (Abstract 7002).
Courtney D. DiNardo, MD, MSCE, of The University of Texas MD Anderson Cancer Center, and Jorge E. Cortes, MD, of Georgia Cancer Center at Augusta University, discuss phase III results from the ASCEMBL trial, which showed that after more than 2 years of follow-up, asciminib continued to yield superior efficacy and better safety and tolerability vs bosutinib in patients with chronic myeloid leukemia (CML) in chronic phase. These results continue to support the use of this kinase inhibitor as a new CML therapy, says Dr. Cortes, with the potential to transform the standard of care (Abstract 7004).
Erika Hamilton, MD, of Sarah Cannon Research Institute at Tennessee Oncology, discusses phase III data from the DESTINY-Breast03 study, which reinforced the consistent safety profile of fam-trastuzumab deruxtecan-nxki (T-DXd) vs ado-trastuzumab emtansine (T-DM1) in patients with HER2-positive unresectable and/or metastatic breast cancer. The findings also support T-DXd’s risk benefit over that of T-DM1 (Abstract 1000).