Olema Pharmaceuticals NasdaqGS:OLMA Stock Report

Olema Oncology Advances OP-1250 into Phase 2 Monotherapy Expansion in Patients with ER+/HER2- Advanced Breast Cancer

Olema Pharmaceuticals, Inc. announced the advancement of OP-1250, a complete estrogen receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD), into Phase 2 clinical development for the treatment of ER+/HER2- metastatic breast cancer. Selection of the recommended Phase 2 dose (RP2D) of 120 mg OP-1250 once-daily was based on pharmacokinetics, safety and tolerability, and encouraging early anti-tumor activity from Phase 1b expansion, which evaluated both 60 mg and 120 mg dose cohorts. As of July 1, 2022, a total of 50 patients had been treated in Phase 1b expansion (N=25 for each cohort). Pharmacokinetic analyses demonstrated dose-proportional exposure of OP-1250, high oral bioavailability, and steady-state plasma levels with minimal peak-to-trough variability. The majority of reported adverse events were Grade 1 or 2 at both dose levels, and the most common treatment-emergent adverse events occurring in =10% of patients were nausea, vomiting, fatigue, and headache, which were similar across both doses.? Two cases of Grade 4 and one case of Grade 3 neutropenia have been observed in patients in the 120 mg cohort of the Phase 1b expansion. One patient with Grade 4 neutropenia paused treatment for one week, restarted at a lower dose and subsequently had an unconfirmed partial response at the first scan. A second patient had Grade 4 febrile neutropenia with no evidence of infection. The patient discontinued treatment and remains off-study. Concurrent with disease progression at 8 weeks, a third patient had Grade 3 neutropenia, which has since resolved. Encouraging early anti-tumor activity continued to be observed, with a total of 4 partial responses in 31 efficacy-evaluable patients in the Phase 1b expansion as of July 1, 2022 (1 confirmed partial response at 60 mg and 3 unconfirmed partial responses, pending confirmation at a subsequent scan, at 120 mg). Phase 2 enrollment continues and will include three cohorts: patients with measurable disease (N=50), patients with non-measurable disease (N=15), and patients with CNS metastasis (N=15). Olema plans to initiate a pivotal monotherapy trial in mid-2023.

Olema Pharmaceuticals, Inc.(NasdaqGS:OLMA) dropped from Russell 2000 Growth Index

Olema Pharmaceuticals, Inc. Provides Clinical Update Reflecting Strong Progress Across OP-1250 Development Program

Olema Pharmaceuticals, Inc. announced clinical development progress for OP-1250, a complete estrogen receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD) in development for the treatment of metastatic breast cancer. Phase 1b Monotherapy Expansion: Successfully achieved 30 patient targeted enrollment (N=15 each for 60 and 120 mg dose cohorts); Favorable tolerability demonstrated, with no grade 3/4 neutropenia and no adverse events that led to discontinuation; Encouraging anti-tumor activity observed, including unconfirmed partial responses (uPRs) in the initial group of patients eligible for efficacy evaluation. Phase 1b Combination with Palbociclib (a CDK4/6 inhibitor): Dose escalation progressing as planned. Two initial cohorts have completed the dose limiting toxicity (DLT) evaluation period (30 and 60 mg cohorts), and the 90 mg dose cohort is ongoing; Combinability demonstrated in initial cohorts, including no DLTs, tolerability consistent with the expected profile of palbociclib plus endocrine therapy, and no induced metabolism of palbociclib. Anticipated Milestones: Select the Recommended Phase 2 Dose (RP2D) for OP-1250 in June 2022, followed by enrollment in the Phase 2 portion of the trial. Phase 2 will include enrollment across three cohorts: patients with measurable disease (N=50), patients with non-measurable disease (N=15) and patients with CNS metastasis (N=15); Initiate a Phase 1b combination study with each of ribociclib, a CDK4/6 inhibitor, and alpelisib, a PI3Ka inhibitor, in third quarter 2022; Present updated monotherapy and initial combination data for OP-1250 in second half of 2022; Initiate a pivotal monotherapy study for OP-1250 in 2023.