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- palazestrant (OP-1250) / Olema Pharma
OPERA-01: A randomized, open-label, phase 3 study of palazestrant (OP-1250) vs standard-of-care for ER+, HER2- advanced or metastatic breast cancer patients after endocrine therapy and CDK4/6 inhibitors. (Hall A; Poster Bd #: 105b) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2564;
P2, P3
OPERA-01 (NCT06016738) is a multicenter, randomized, open-label, phase 3 clinical trial comparing the efficacy and safety of palazestrant as a single agent to SOC ET (fulvestrant, anastrozole, letrozole, or exemestane) in patients with ER+, HER2
- palazestrant (OP-1250) / Olema Pharma, Kisqali (ribociclib) / Novartis
A Phase 1b/2 study of palazestrant (OP-1250) in combination with ribociclib in patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) metastatic breast cancer (Exhibition area) - Mar 19, 2024 - Abstract #ESMOBC2024ESMO_BC_461;
P1
No new safety signals were identified. Antitumor activity and clinical benefit, including in heavily pretreated patients, were observed.
- || palazestrant (OP-1250) / Olema Pharma
Phase classification, Enrollment change, Combination therapy, Metastases: Phase 1b Combo w/ Ribociclib and Alpelisib (clinicaltrials.gov) - Jan 11, 2024
P1, N=90, Recruiting, Sponsor: Olema Pharmaceuticals, Inc.
Antitumor activity and clinical benefit, including in heavily pretreated patients, were observed. Phase classification: P1b --> P1 | N=60 --> 90
- | palazestrant (OP-1250) / Olema Pharma
Preclinical, Journal, Monotherapy: Palazestrant (OP-1250), a Complete Estrogen Receptor Antagonist, Inhibits Wild-type and Mutant ER-positive Breast Cancer Models as Monotherapy and in Combination. (Pubmed Central) - Dec 16, 2023
OP-1250 combines well with cyclin-dependent kinase 4 and 6 inhibitors in xenograft studies of ER+ breast cancer models and effectively shrinks intracranially implanted tumors, resulting in prolonged animal survival. With demonstrated preclinical efficacy exceeding fulvestrant in wild-type models, elacestrant in ESR1-mutant models, and tamoxifen in intracranial xenografts, OP-1250 has the potential to benefit patients with ER+ breast cancer.
- |||||| palazestrant (OP-1250) / Olema Pharma
Enrollment open, Monotherapy, Metastases: OPERA-01: OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer (clinicaltrials.gov) - Nov 13, 2023
P3, N=510, Recruiting, Sponsor: Olema Pharmaceuticals, Inc.
With demonstrated preclinical efficacy exceeding fulvestrant in wild-type models, elacestrant in ESR1-mutant models, and tamoxifen in intracranial xenografts, OP-1250 has the potential to benefit patients with ER+ breast cancer. Not yet recruiting --> Recruiting
- Piqray (alpelisib) / Novartis, palazestrant (OP-1250) / Olema Pharma, Kisqali (ribociclib) / Novartis
A Phase 1b/2 study of palazestrant (OP-1250) in combination with ribociclib or alpelisib in patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative, advanced and/or metastatic breast cancer (Hall 2-3) - Nov 4, 2023 - Abstract #SABCS2023SABCS_1416;
P1b
No new safety signals were observed for the 3 drugs, and no clinically significant DDIs were observed between palazestrant and ribociclib or alpelisib at the doses evaluated. Exposure of each drug was consistent with observed monotherapy exposure levels.
- palazestrant (OP-1250) / Olema Pharma
OPERA-01: A randomized, open-label, phase 3, study of palazestrant (OP-1250) vs standard-of-care treatment for ER+, HER2- advanced or metastatic breast cancer after endocrine and CDK4/6 inhibitor therapy (Hall 2-3) - Nov 4, 2023 - Abstract #SABCS2023SABCS_1258;
P2
Secondary endpoints include overall survival, antitumor activity (objective response rate, clinical benefit rate, and duration of response), safety, patient-reported outcomes, and PK in pts with and without ESR1 mutations. The study is planned to be conducted globally.
- Ibrance (palbociclib) / Pfizer, palazestrant (OP-1250) / Olema Pharma
A Phase 1b/2 study of palazestrant (OP-1250), an oral complete estrogen receptor antagonist (CERAN) and selective ER degrader (SERD), with palbociclib in ER-positive, HER2-negative, advanced or metastatic breast cancer patients (Stars at Night Ballroom 1-2) - Nov 4, 2023 - Abstract #SABCS2023SABCS_396;
Tumor responses and clinical benefit were observed in this population of patients, including those who received prior CDK4/6 inhibitors. Expanding on our previous report, these data provide the rationale to continue advancing the clinical development of palazestrant with the approved dose of palbociclib.
- The discovery of potent KAT6 inhibitors that demonstrate anti-tumor activity in preclinical models of ER+ breast cancer. (LEVEL 2, EXHIBIT HALL D) - Sep 16, 2023 - Abstract #AACRNCIEORTC2023AACR_NCI_EORTC_204;
- SERMs versus SERDs for targeting ESR1 mutations (Hemisfair Ballroom 1-2) - Sep 12, 2023 - Abstract #SABCS2023SABCS_131;
- |||||||||| palazestrant (OP-1250) / Olema Pharma
New P3 trial, Monotherapy, Metastases: OPERA-01: OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer (clinicaltrials.gov) - Aug 30, 2023
P3, N=510, Not yet recruiting, Sponsor: Olema Pharmaceuticals, Inc.
- || palazestrant (OP-1250) / Olema Pharma
Enrollment closed, Monotherapy, Metastases: OP-1250-001: A Dose Escalation/Expansion Study of Oral OP-1250 in Subjects With Advanced and/or Metastatic HR+, HER2- Breast Cancer (clinicaltrials.gov) - Aug 22, 2023
P2, N=153, Active, not recruiting, Sponsor: Olema Pharmaceuticals, Inc.
Expanding on our previous report, these data provide the rationale to continue advancing the clinical development of palazestrant with the approved dose of palbociclib. Recruiting --> Active, not recruiting
- palazestrant (OP-1250) / Olema Pharma
Updated results from the phase I/II study of OP-1250, an oral complete estrogen receptor (ER) antagonist (CERAN) and selective ER degrader (SERD) in patients (pts) with advanced or metastatic ER-positive, HER2-negative breast cancer (Bilbao Auditorium - NCC) - Jul 27, 2023 - Abstract #ESMO2023ESMO_794;
P2
Conclusions OP-1250 (120 mg qd) was well tolerated with promising efficacy in heavily pretreated pts, including pts progressing on fulvestrant and CDK4/6i. A phase 3 monotherapy study in metastatic BC (second/third line) is planned in 2023.
- ||| palazestrant (OP-1250) / Olema Pharma
Phase classification, Enrollment change, Trial completion date, Trial primary completion date, Monotherapy, Metastases: OP-1250-001: A Dose Escalation/Expansion Study of Oral OP-1250 in Subjects With Advanced and/or Metastatic HR+, HER2- Breast Cancer (clinicaltrials.gov) - Apr 27, 2023
P2, N=161, Recruiting, Sponsor: Olema Pharmaceuticals, Inc.
A phase 3 monotherapy study in metastatic BC (second/third line) is planned in 2023. Phase classification: P1/2 --> P2 | N=94 --> 161 | Trial completion date: Dec 2023 --> Jul 2024 | Trial primary completion date: Oct 2023 --> Jun 2024
- Piqray (alpelisib) / Novartis, OP-1250 / Olema Pharma, Kisqali (ribociclib) / Novartis
A phase 1b/2 dose escalation and expansion study of OP-1250 in combination with ribociclib or alpelisib in patients with advanced and/or metastatic estrogen receptor (On Demand | Hall A; Poster Bd # 340a) - Apr 26, 2023 - Abstract #ASCO2023ASCO_3319;
P1b
Enrollment at approximately 20 sites in the United States and Australia is ongoing. Clinical trial information: NCT05508906.
- Ibrance (palbociclib) / Pfizer, OP-1250 / Olema Pharma
A phase 1b/2 study of OP-1250, an oral complete estrogen receptor (ER) antagonist (CERAN) and selective ER degrader (SERD) with palbociclib in patients (pts) with advanced or metastatic ER-positive, HER2-negative breast cancer (MBC) (Exhibition area) - Mar 22, 2023 - Abstract #ESMOBC2023ESMO_BC_456;
Updated data will be presented. (NCT0526610).
- Ibrance (palbociclib) / Pfizer, OP-1250 / Olema Pharma
Preliminary data from a Phase 1b dose escalation study of OP-1250, an oral CERAN, in combination with palbociclib in patients with advanced and/or metastatic estrogen receptor (ER)-positive, HER2-negative breast cancer (Hall 1) - Oct 10, 2022 - Abstract #SABCS2022SABCS_912;
P1, P1/2
There were no clinically significant DDIs observed between OP-1250 and palbociclib at the doses evaluated and exposure of each drug was consistent with observed monotherapy exposure levels. Dose escalation of OP-1250 continues to 120 mg, to be followed by dose expansion.
- OP-1250 / Olema Pharma
Combination of complete estrogen receptor antagonist, OP-1250, and CDK4/6 inhibitors enhances tumor suppression and inhibition of cell cycle-related gene expression (Hall 1) - Oct 10, 2022 - Abstract #SABCS2022SABCS_733;
This study supports the clinical evaluation of OP-1250 in combination with CDK4/6 inhibitors (palbociclib or ribociclib) and provides additional context to mechanisms of combination efficacy. OP-1250 is currently being evaluated in a Phase Ib clinical trial in combination with palbociclib and a study including evaluation of the combination of OP-1250 with ribociclib is planned to initiate in Q3 2022.
- ||| palazestrant (OP-1250) / Olema Pharma
Enrollment open, Combination therapy, Metastases: Phase 1b Combo w/ Ribociclib and Alpelisib (clinicaltrials.gov) - Sep 26, 2022
P1b, N=60, Recruiting, Sponsor: Olema Pharmaceuticals, Inc.
OP-1250 is currently being evaluated in a Phase Ib clinical trial in combination with palbociclib and a study including evaluation of the combination of OP-1250 with ribociclib is planned to initiate in Q3 2022. Not yet recruiting --> Recruiting
- OP-1250 / Olema Pharma
Phase 1b results from OP-1250-001, a dose escalation and dose expansion study of OP-1250, an oral CERAN, in subjects with advanced and/or metastatic estrogen receptor (ER)-positive, HER2-negative breast cancer (NCT04505826) (Exhibition Hall) - Sep 3, 2022 - Abstract #AACRNCIEORTC2022AACR_NCI_EORTC_228;
P1/2
Based on safety and pharmacokinetic data, a RP2D will be selected. A Phase 2 evaluation will be initiated, and a Phase 3 monotherapy study is planned for 2023.
- ||| palazestrant (OP-1250) / Olema Pharma
New P1 trial, Combination therapy, Metastases: Phase 1b Combo w/ Ribociclib and Alpelisib (clinicaltrials.gov) - Aug 19, 2022
P1b, N=60, Not yet recruiting, Sponsor: Olema Pharmaceuticals, Inc.
- | palazestrant (OP-1250) / Olema Pharma
New P1 trial, Combination therapy, Metastases: A Study of OP-1250 in Combination with the CDK4/6 Inhibitor Palbociclib in Adult Subjects with Advanced or Metastatic hormone receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative) Breast Cancer (EUDRACT) - Apr 1, 2022
P1, N=30, Not yet recruiting, Sponsor: Olema Pharmaceuticals, Inc.
- OP-1250 / Olema Pharma
Precision run-on sequencing (PRO-seq) analysis of a treatment time course in ER+ breast cancer cell lines reveals the transcriptional changes underlying response to complete estrogen receptor antagonist (CERAN) OP-1250 (Section 24) - Mar 9, 2022 - Abstract #AACR2022AACR_6792;
These data provide additional insights into the mechanisms of OP-1250 action on ER+ cell lines and patient tumors. OP-1250 is currently in a Phase I/II clinical trial for the treatment of ER+ breast cancer.
- OP-1250 / Olema Pharma
OP-1250 prevents tumor spread in a model of metastatic mutant ERĪ±+ breast cancer (Section 11) - Mar 9, 2022 - Abstract #AACR2022AACR_4376;
Mice were treated with 3 and 10 mg/kg of OP-1250 alone or in combination with palbociclib at 70mg/kg and tumor growth was monitored via a Xenogen IVIS imager...OP-1250 at both doses inhibited primary tumor growth as well as metastasis to the lung, liver, brain and bone, with greater effect at 10 mg/kg, and was significantly more effective than Faslodex...Our results also suggest that the efficacy seen in the combination study was driven primarily by OP-1250. In total, these results demonstrate the potential use of OP-1250, both alone and in combination with a CDK4/6 inhibitor, to inhibit tumor growth and metastasis in a model of aggressive mutant ER+ MBC.
- || palazestrant (OP-1250) / Olema Pharma
New P1 trial, Combination therapy, Metastases: OP-1250-002: A Phase 1 Study of Oral OP-1250 in Combination With Palbociclib in HR+/HER2- Breast Cancer Patients (clinicaltrials.gov) - Mar 4, 2022
P1, N=30, Recruiting, Sponsor: Olema Pharmaceuticals, Inc.
- |||| ARV-471 / Arvinas, OP-1250 / Olema Pharma
Clinical: 11 good months on ARV471 PROTAC trial, my longest MBC treatment. Hoping to get into OP 1250 CERAN trial next. Trying to stay calm for my 7th MBC liver biopsy tomorrow! Thankful @sarahcannondocs @erikahamilton9 #clinicaltrials #GRASPcancer #bcsm (Twitter) - Nov 4, 2021
- | OP-1250 / Olema Pharma
All eyes should be on $olma OP-1250 (Twitter) - Oct 30, 2021
- OP-1250 / Olema Pharma, Herceptin (trastuzumab) / Roche
The complete estrogen receptor antagonist OP-1250 can combine with HER2 inhibition to inhibit estrogen receptor-driven cellular proliferation and shrink xenograft tumors in ER+/HER2+ breast cancer models (Hall 1) - Oct 26, 2021 - Abstract #SABCS2021SABCS_1316;
The addition of OP-1250 to a HER2 inhibitor also resulted in greater tumor shrinkage in multiple ER+/HER2+ xenograft models. Our data suggests a potential clinical benefit in the addition of OP-1250 on top of HER2 inhibition for the treatment of ER+/HER2+ breast cancer and provides strong rationale for a clinical study evaluating the combination of OP-1250 and HER2 targeted agents, which is planned for 2022.
- OP-1250 / Olema Pharma
Preliminary data from a phase I/II, multicenter, dose escalation study of OP-1250, an oral CERAN/SERD, in subjects with advanced and/or metastatic estrogen receptor (ER)-positive, HER2-negative breast cancer (Hall 1) - Oct 26, 2021 - Abstract #SABCS2021SABCS_560;
P1/2
The population enrolled reflects the evolving standard of care in that all pts received prior CDK4/6 inhibitors and the majority also received fulvestrant. OP-1250 is well tolerated with a favorable PK across dose levels ensuring target coverage throughout the dosing interval.
- | palazestrant (OP-1250) / Olema Pharma
New P1 trial, Combination therapy, Metastases: A Study of OP-1250 in Combination with the CDK4/6 Inhibitor Palbociclib in Adult Subjects with Advanced or Metastatic hormone receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative) Breast Cancer (EUDRACT) - Oct 24, 2021
P1, N=30, Not yet recruiting, Sponsor: Olema Pharmaceuticals, Inc.
- OP-1250 / Olema Pharma
[VIRTUAL] A Phase 1/2 Dose Escalation and Expansion Study of OP-1250 in Adults with Advanced and/or Metastatic Hormone Receptor-positive (HR+), HER2-negative (HER2-) Breast Cancer () - Sep 30, 2021 - Abstract #AACRNCIEORTC2021AACR_NCI_EORTC_196;
- OP-1250 / Olema Pharma
[VIRTUAL] The complete estrogen receptor antagonist (CERAN) OP-1250 shrinks ER+ brain metastases in an intracranial xenograft tumor model expressing mutant ESR1 () - Mar 11, 2021 - Abstract #AACR2021AACR_508;
Here we compare the ability of OP-1250 to shrink brain tumors in this model with tamoxifen and other agents. Whereas tamoxifen indeed had therapeutic effects in this brain xenograft model, the effect was not as profound as that of OP-1250, which was able to completely clear the tumors in many animals, as determined by MRI.*
- |||| OP-1250 / Olema Pharma
Clinical: Watch Dr. @ErikaHamilton9 discuss the mechanism of action of OP-1250 in patients with hormone receptor–positive, HER2-negative metastatic breast cancer in this episode of @OncLive TV. https://t.co/3AxLaSFy3B (Twitter) - Jan 19, 2021
- |||| OP-1250 / Olema Pharma
Clinical: Erika P. Hamilton, MD, discusses the mechanism of action of OP-1250 in patients with hormone receptor–positive, HER2-negative metastatic breast cancer. @ErikaHamilton9 @SarahCannonDocs @SABCSSanAntonio #SABCS20 https://t.co/XBgnKmnXjO (Twitter) - Dec 13, 2020
- |||| OP-1250 / Olema Pharma
Clinical, P1/2 data, Monotherapy: .@ErikaHamilton9 presents ongoing trials in #SABCS20 poster, 'A Phase I/II Open-label, First-in-Human, Multicenter, Dose Escalation and Dose Expansion Study of OP-1250 monotherapy in adult subjects with advanced and/or metastatic HR+, HER2- breast cancer.' abstract OT-09-10. (Twitter) - Dec 9, 2020
- OP-1250 / Olema Pharma
[VIRTUAL] A phase I/II open-label, first-in-human, multicenter, dose escalation and dose expansion study of OP-1250 monotherapy in adult subjects with advanced and/or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer () - Oct 2, 2020 - Abstract #SABCS2020SABCS_1105;
To conduct a preliminary assessment of the antitumor activity (ORR) of OP-1250 in subjects with HR+, HER2- MBC who have progressed on endocrine therapy and have CNS disease. Assessment of response will be determined according to RECIST 1.1 and Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria Correlative Science To determine biomarker expression, such as, ER, PR, Ki67 and others in the most recently obtained archival tumor tissue sample To evaluate whether ESR1 in circulating tumor DNA (ctDNA) can be correlated with response and/or activity of OP-1250 To examine ctDNA pre- and post-therapy for mutESR1 and PIK3CA variants, and other relevant markers For more information, please contact clinical@olemapharma.com
- OP-1250 / Olema Pharma
[VIRTUAL] The complete estrogen receptor antagonist OP-1250 shrinks tumors in xenograft models and has favorable preclinical pharmacokinetic attributes (OnDemand) - Oct 2, 2020 - Abstract #SABCS2020SABCS_1014;
These preclinical studies indicate that OP-1250 has the potential to be a best-in-class antiestrogen due to its ability to complete antagonize ER, potent efficacy in shrinking tumors, and robust drug exposure. A Phase 1/2 dose escalation and expansion study in patients with ER+, HER2- metastatic or advanced BC previously treated with an endocrine therapy will be initiated this year.
- OP-1250 / Olema Pharma
[VIRTUAL] OP-1250: a potent orally available complete antagonist of estrogen receptor-mediated signaling that shrinks wild type and mutant breast tumors () - Sep 7, 2020 - Abstract #AACRNCIEORTC2020AACR_NCI_EORTC_356;
OP-1250 is orally available in all tested species, completely antagonizes both AF1 and AF2 of the ER, degrades the receptor, and shrinks breast tumors expressing both wild type and mutant receptor. A Phase 1/2 dose escalation and expansion study in patients with ER-positive, HER2-negative metastatic or advanced breast cancer previously treated with an endocrine therapy will be initiated this year.
- OP-1250 / Olema Pharma
[VIRTUAL] OP-1250: a potent orally available complete antagonist of estrogen receptor-mediated signaling that shrinks wild type and mutant breast tumors () - Sep 7, 2020 - Abstract #AACRNCIEORTC2020AACR_NCI_EORTC_355;
OP-1250 is orally available in all tested species, completely antagonizes both AF1 and AF2 of the ER, degrades the receptor, and shrinks breast tumors expressing both wild type and mutant receptor. A Phase 1/2 dose escalation and expansion study in patients with ER-positive, HER2-negative metastatic or advanced breast cancer previously treated with an endocrine therapy will be initiated this year.
- | palazestrant (OP-1250) / Olema Pharma
Enrollment open, Monotherapy, Metastases: OP-1250-001: A Dose Escalation/Expansion Study of Oral OP-1250 in Subjects With Advanced and/or Metastatic HR+, HER2- Breast Cancer (clinicaltrials.gov) - Aug 20, 2020
P1/2, N=94, Recruiting, Sponsor: Olema Pharmaceuticals, Inc.
A Phase 1/2 dose escalation and expansion study in patients with ER-positive, HER2-negative metastatic or advanced breast cancer previously treated with an endocrine therapy will be initiated this year. Not yet recruiting --> Recruiting
- | palazestrant (OP-1250) / Olema Pharma
New P1/2 trial, Monotherapy, Metastases: OP-1250-001: A Dose Escalation/Expansion Study of Oral OP-1250 in Subjects With Advanced and/or Metastatic HR+, HER2- Breast Cancer (clinicaltrials.gov) - Aug 9, 2020
P1/2, N=94, Not yet recruiting, Sponsor: Olema Pharmaceuticals, Inc.