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ASCO 2022 | ECOG-ACRIN E2211: MGMT predictive of response to temozolomide in advanced pancreatic NETs

Pamela L. Kunz, MD, Yale University School of Medicine, New Haven, CT, reports on the final analysis of efficacy and evaluation of MGMT as a predictive biomarker of the randomized Phase II ECOG-ACRIN E2211 (NCT01824875) trial investigating temozolomide or temozolomide plus capecitabine in patients with advanced pancreatic neuroendocrine tumors (pNETs). The primary endpoint of the Phase II trial was progression-free survival (PFS) and secondary endpoints included response rate and overall-survival (OS). MGMT deficiency is predictive of response to temozolomide in glioblastoma and was a correlative endpoint as a predictive biomarker of response to temozolomide in patients with pNETs in this study. An interim-analysis demonstrated the primary endpoint was met, with the combination arm achieving 22.7 months PFS versus 14 months for temozolomide monotherapy. An updated analysis showed no significant difference in OS between the two arms. Patients who achieved a response were MGMT-deficient, a statistically significant finding indicating MGMT levels is associated with response to temozolomide in this patient population. This interview took place at the American Society of Clinical Oncology (ASCO) 2022 Annual Meeting in Chicago, IL.