Olema and Novartis expand Phase 1/2 combo study of palazestrant + ribociclib to ~60 patients

Olema Pharmaceuticals, Inc.

Amendment adds ~30 patients to dose expansion, increasing study size to about 60 total.
Phase 1b dose escalation completed; Phase 2 expansion at 120 mg palazestrant + 600 mg ribociclib.
Expanded dataset may support regulatory path for a first-line pivotal trial in ER+ breast cancer.
Collaboration originally signed July 2020; amended in January 2022 and now expanded again.
Olema (OLMA) and Novartis (NVS) partner on this combination trial.

Key facts

Extracted from this filing and checked against the source text.

Material Agreements SEC 8-K Item 1.01/1.02 confidence 0.9

Olema Pharmaceuticals, Inc. amended Amendment No. 1 to Amended and Restated Clinical Collaboration and Supply Agreement with Novartis Institutes for BioMedical Research, Inc. (effective 2023-10-09).

Action: amendment
Agreement: collaboration
Counterparty: Novartis Institutes for BioMedical Research, Inc.
Effective: 2023-10-09

Exact text from the filing

On October 9, 2023, Olema Pharmaceuticals, Inc. (the “Company”) entered into an Amendment No. 1 to Amended and Restated Clinical Collaboration and Supply Agreement (the “Amendment”) with Novartis Institutes for BioMedical Research, Inc. (“Novartis”).

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Olema Pharmaceuticals, Inc. filing history →

Source: SEC EDGAR

accession 0001558370-23-016301

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