- Results demonstrate ZEJULA activity beyond patients with BRCA mutations in late-line ovarian cancer treatment setting
- QUADRA data accepted for presentation at 2018 ASCO annual meeting
- Data intended to support label expansion with biomarker in the treatment setting
WALTHAM, MA, USA I April 24, 2018 I TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced results from the QUADRA study, which was designed to assess clinical benefit of ZEJULA® treatment in heavily pre-treated patients with ovarian cancer. Results successfully achieved the pre-specified primary endpoint and demonstrated ZEJULA monotherapy activity in a biomarker selected patient population.
Previous studies have shown PARP inhibitor activity in the late-line treatment of patients with BRCA mutations. QUADRA, a single arm study (n=461), was conducted to assess the activity of ZEJULA monotherapy in the fourth-line plus treatment of specific ovarian cancer patient populations. Of the 92% of QUADRA participants who were PARP inhibitor naïve, 15% had a BRCA mutation, over two-thirds were platinum resistant/refractory and 63% had received prior bevacizumab.
ZEJULA demonstrated activity in the primary efficacy population of fourth and fifth-line HRD positive patients who were PARP inhibitor naïve, and platinum sensitive (n=45), with an objective response rate (ORR) of 29%, and duration of response (DOR) of 9.2 months. In patients who were fourth line or greater with BRCA mutations, including platinum-sensitive, resistant and refractory, (n=55), the ORR was 31% and the median DOR was 9.4 months.
At a starting dose of 300 milligrams of ZEJULA, the most commonly observed adverse events were consistent with prior clinical experience and included myelosuppression, which was generally managed via dose modifications. TESARO intends to discuss a biomarker focused regulatory submission with the U.S. Food and Drug Administration (FDA) for a potential supplemental New Drug Application (sNDA) in the second half of 2018.
“These results demonstrated that ZEJULA is active as a late-line treatment for patients beyond those with BRCA mutations, which is the only treatment setting in which PARP inhibitors are approved today. In addition, the QUADRA data describe ZEJULA monotherapy activity in platinum-resistant/refractory patients, providing important context for our TOPACIO study of ZEJULA in combination with an anti-PD-1 inhibitor,” said Mary Lynne Hedley, President and COO of TESARO. “With QUADRA data in hand, we continue to advance our mission to provide all patients with ovarian cancer an opportunity to benefit from treatment with ZEJULA, and we are extremely grateful to the patients, caregivers, and investigators who took part in this study.”
Beyond QUADRA, clinical trials of niraparib in ovarian cancer include:
First Line:
- PRIMA: Monotherapy Phase 3 trial for patients with first-line ovarian cancer regardless of biomarker status expected to complete enrollment in Q2 2018; data anticipated in 2019
- OVARIO: Combination Phase 2 trial assessing ZEJULA with bevacizumab for patients with newly diagnosed ovarian cancer
- FIRST: Combination Phase 3 clinical trial of chemotherapy ± TSR-042, and ZEJULA in first-line ovarian cancer to be initiated in 1H 2018
Recurrent:
- NOVA: Monotherapy Phase 3 trial for patients with platinum sensitive, recurrent ovarian cancer, regardless of biomarker status (complete; patients being followed for overall survival)
- AVANOVA: Combination Phase 2 trial with bevacizumab for patients with recurrent ovarian cancer; anticipate data to be available in 2H 2018 to support data submission for a meeting held in 2019
Platinum-Resistant:
- TOPACIO: Combination Phase 2 trial with anti-PD-1 for patients with platinum-resistant ovarian cancer or triple negative breast cancer (abstracts accepted for presentation at ASCO)
Product Lifecycle:
- A tablet formulation of ZEJULA is in development.
About the QUADRA Clinical Trial
QUADRA is an open-label, single arm trial designed to evaluate the safety and efficacy of ZEJULA in the treatment setting of ovarian cancer. Patients were enrolled and received a starting dose of 300 milligrams of niraparib once per day. The primary endpoint of this study was objective response rate (ORR) per RECIST in the fourth and fifth-line HRD positive patients who were PARP inhibitor naïve, and platinum sensitive. Other endpoints include durability of response, disease control rate, progression free survival (PFS), overall survival (OS) and safety and tolerability.
About ZEJULA® (Niraparib)
Niraparib is marketed in the United States and Europe under trade name ZEJULA®. ZEJULA (niraparib) is a poly(ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. In preclinical studies, ZEJULA concentrates in the tumor relative to plasma, delivering greater than 90% durable inhibition of PARP 1/2 and a persistent antitumor effect.
About TESARO
TESARO is an oncology-focused biopharmaceutical company dedicated to improving the lives of cancer patients by acquiring, developing and commercializing safer and more effective therapeutics. For more information, visit www.tesarobio.com.
SOURCE: TESARO
Post Views: 21
- Results demonstrate ZEJULA activity beyond patients with BRCA mutations in late-line ovarian cancer treatment setting
- QUADRA data accepted for presentation at 2018 ASCO annual meeting
- Data intended to support label expansion with biomarker in the treatment setting
WALTHAM, MA, USA I April 24, 2018 I TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced results from the QUADRA study, which was designed to assess clinical benefit of ZEJULA® treatment in heavily pre-treated patients with ovarian cancer. Results successfully achieved the pre-specified primary endpoint and demonstrated ZEJULA monotherapy activity in a biomarker selected patient population.
Previous studies have shown PARP inhibitor activity in the late-line treatment of patients with BRCA mutations. QUADRA, a single arm study (n=461), was conducted to assess the activity of ZEJULA monotherapy in the fourth-line plus treatment of specific ovarian cancer patient populations. Of the 92% of QUADRA participants who were PARP inhibitor naïve, 15% had a BRCA mutation, over two-thirds were platinum resistant/refractory and 63% had received prior bevacizumab.
ZEJULA demonstrated activity in the primary efficacy population of fourth and fifth-line HRD positive patients who were PARP inhibitor naïve, and platinum sensitive (n=45), with an objective response rate (ORR) of 29%, and duration of response (DOR) of 9.2 months. In patients who were fourth line or greater with BRCA mutations, including platinum-sensitive, resistant and refractory, (n=55), the ORR was 31% and the median DOR was 9.4 months.
At a starting dose of 300 milligrams of ZEJULA, the most commonly observed adverse events were consistent with prior clinical experience and included myelosuppression, which was generally managed via dose modifications. TESARO intends to discuss a biomarker focused regulatory submission with the U.S. Food and Drug Administration (FDA) for a potential supplemental New Drug Application (sNDA) in the second half of 2018.
“These results demonstrated that ZEJULA is active as a late-line treatment for patients beyond those with BRCA mutations, which is the only treatment setting in which PARP inhibitors are approved today. In addition, the QUADRA data describe ZEJULA monotherapy activity in platinum-resistant/refractory patients, providing important context for our TOPACIO study of ZEJULA in combination with an anti-PD-1 inhibitor,” said Mary Lynne Hedley, President and COO of TESARO. “With QUADRA data in hand, we continue to advance our mission to provide all patients with ovarian cancer an opportunity to benefit from treatment with ZEJULA, and we are extremely grateful to the patients, caregivers, and investigators who took part in this study.”
Beyond QUADRA, clinical trials of niraparib in ovarian cancer include:
First Line:
- PRIMA: Monotherapy Phase 3 trial for patients with first-line ovarian cancer regardless of biomarker status expected to complete enrollment in Q2 2018; data anticipated in 2019
- OVARIO: Combination Phase 2 trial assessing ZEJULA with bevacizumab for patients with newly diagnosed ovarian cancer
- FIRST: Combination Phase 3 clinical trial of chemotherapy ± TSR-042, and ZEJULA in first-line ovarian cancer to be initiated in 1H 2018
Recurrent:
- NOVA: Monotherapy Phase 3 trial for patients with platinum sensitive, recurrent ovarian cancer, regardless of biomarker status (complete; patients being followed for overall survival)
- AVANOVA: Combination Phase 2 trial with bevacizumab for patients with recurrent ovarian cancer; anticipate data to be available in 2H 2018 to support data submission for a meeting held in 2019
Platinum-Resistant:
- TOPACIO: Combination Phase 2 trial with anti-PD-1 for patients with platinum-resistant ovarian cancer or triple negative breast cancer (abstracts accepted for presentation at ASCO)
Product Lifecycle:
- A tablet formulation of ZEJULA is in development.
About the QUADRA Clinical Trial
QUADRA is an open-label, single arm trial designed to evaluate the safety and efficacy of ZEJULA in the treatment setting of ovarian cancer. Patients were enrolled and received a starting dose of 300 milligrams of niraparib once per day. The primary endpoint of this study was objective response rate (ORR) per RECIST in the fourth and fifth-line HRD positive patients who were PARP inhibitor naïve, and platinum sensitive. Other endpoints include durability of response, disease control rate, progression free survival (PFS), overall survival (OS) and safety and tolerability.
About ZEJULA® (Niraparib)
Niraparib is marketed in the United States and Europe under trade name ZEJULA®. ZEJULA (niraparib) is a poly(ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. In preclinical studies, ZEJULA concentrates in the tumor relative to plasma, delivering greater than 90% durable inhibition of PARP 1/2 and a persistent antitumor effect.
About TESARO
TESARO is an oncology-focused biopharmaceutical company dedicated to improving the lives of cancer patients by acquiring, developing and commercializing safer and more effective therapeutics. For more information, visit www.tesarobio.com.
SOURCE: TESARO
Post Views: 21
