Capsitonin (calcitonin) / Botanix Pharma, Proxima Concepts - LARVOL DELTA

Dual Immune Check Point Blockade in MGMT-Unmethylated Newly Diagnosed Glioblastoma: NRG Oncology BN007, a Randomized Phase II/III Clinical Trial. (PubMed, J Clin Oncol) - "Ipi and nivo did not improve PFS among patients with newly diagnosed uMGMT glioblastoma versus TMZ. Accrual closed permanently; the trial will not proceed to phase III. No new safety signals were identified. Molecular correlative analyses and survival follow-up are ongoing."

IO biomarker • Journal • P2/3 data • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • MGMT

NRG-BN002: Phase I Study of Ipilimumab, Nivolumab, and the Combination in Patients with Newly Diagnosed GBM. (PubMed, Neuro Oncol) - "IPI and NIVO are safe and tolerable with toxicities similar to those noted with other cancers when given in combination with adjuvant TMZ for newly diagnosed GBM. Combination IPI+NIVO is not substantially more toxic than single agents. These results support a subsequent efficacy trial to test the combination of ICIs in a phase II/III for patients with newly diagnosed GBM."

Journal • P1 data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

NRG Oncology Study BN007: Randomized phase II/III trial of ipilimiumab (Ipi) plus nivolumab (Nivo) vs. temozolomide (TMZ) in MGMT-unmethylated (uMGMT) newly diagnosed glioblastoma (nGBM) (SNO 2023) - P2/3 | "NRG Oncology BN002 (phase I) demonstrated safety and preliminary efficacy of Ipi+Nivo for nGBM, leading to BN007 as phase II/III. Ipi+Nivo did not improve PFS for uMGMT nGBM. Accrual permanently closed after phase II. No new safety signals were identified."

Clinical • P2/3 data • Brain Cancer • CNS Tumor • Gastroenterology • Gastrointestinal Disorder • Glioblastoma • Glioma • Immunology • Oncology • Solid Tumor • MGMT

NRG BN002: SAFETY DATA FROM A PHASE I STUDY OF IPILIMUMAB (IPI), NIVOLUMAB (NIVO), AND THE COMBINATION FOR NEWLY DIAGNOSED GLIOBLASTOMA (GBM) (SNO 2018) - "This study evaluated the safety of anti-CTLA-4 (IPI) and anti-PD-1 (NIVO) ICIs alone or in combination in newly diagnosed GBM during adjuvant temozolomide (TMZ) treatment. This phase I study evaluated IPI (3mg/kg), NIVO (3mg/kg), and the combination (1 mg/kg & 3 mg/kg respectively) followed by an expansion cohort for the combined treatment of adults with unifocal, supratentorial newly diagnosed GBM after gross or near total resection. IPI and NIVO are safe and tolerable with similar toxicity profiles noted with other cancers when given with adjuvant TMZ for newly diagnosed GBM. Combination IPI+NIVO is not more toxic than single agents. These results provide necessary safety data for a subsequent efficacy trial to test the combination of ICIs in newly diagnosed GBM."

Clinical • P1 data • Brain Cancer • Oncology

NRG BN002: Phase I study of checkpoint inhibitors anti-CTLA-4, anti-PD-1, the combination in patients with newly diagnosed glioblastoma. (ASCO 2018) - P1; "This study evaluated the safety of anti-CTLA-4 (Ipilimumab; IPI) and anti-PD-1 (Nivolumab; NIVO) ICIs alone or in combination in newly diagnosed GBM during adjuvant temozolomide (TMZ) treatment. IPI and NIVO are safe and tolerable with similar toxicity profiles noted with other cancers when given with adjuavant TMZ for newly diagnosed GBM. These results provide necessary safety data justifying the performance of a subsequent trial to test the efficacy of ICIs in this disease."

Checkpoint inhibition • Clinical • P1 data • Hematological Malignancies