LYNPARZA Met Primary Endpoint of Progression-Free Survival in Women with BRCA-Mutated Advanced Ovarian Cancer and Showed a Safety Profile Consistent with Previous Trials
AstraZeneca and Merck’s LYNPARZA is the Only PARP Inhibitor to Demonstrate Significant Activity in the First-Line Maintenance Setting
AstraZeneca and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced positive results from the randomized, double-blinded, placebo-controlled, Phase 3 SOLO-1 trial of LYNPARZA® (olaparib) tablets.
Women with BRCA-mutated (BRCAm) advanced ovarian cancer treated first-line with LYNPARZA maintenance therapy had a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to placebo. The safety and tolerability profile of LYNPARZA was consistent with previous trials. Based upon these data, AstraZeneca and Merck plan to initiate discussions with health authorities regarding regulatory submissions.
Sean Bohen, executive vice president, global medicines development and chief medical officer at AstraZeneca, said, “For the first time, we see a significant and clinically impactful improvement in progression-free survival in the first-line maintenance setting for women with BRCA-mutated ovarian cancer treated with a PARP inhibitor. The SOLO-1 data reinforce the importance of knowing BRCA status at diagnosis, as this may enable women with BRCA-mutated ovarian cancer to receive LYNPARZA earlier. We would like to thank the investigators, hospitals and most of all the patients who took part in this trial, without whom medical advancements would not be possible.”
Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said, “Building on the strong data we’ve seen with LYNPARZA to date, the data from SOLO-1 reinforce LYNPARZA’s ability to provide meaningful disease control with a well-characterized safety and tolerability profile. We look forward to presenting the full data set for SOLO-1 at a future medical meeting and working with the regulatory authorities to bring LYNPARZA to women with ovarian cancer in the first-line maintenance setting as quickly as possible.”
LYNPARZA is not currently FDA-approved for 1st-line ovarian maintenance treatment. LYNPARZA is indicated for the maintenance treatment of recurrent ovarian cancer in response to platinum-based chemotherapy regardless of BRCA mutation status, and for the treatment of advanced ovarian cancer patients with a gBRCA-mutation previously treated with three or more lines of chemotherapy. Physicians should select advanced ovarian cancer patients for therapy based on a FDA-approved companion diagnostic. Please see Indications for LYNPARZA® (olaparib) 100 mg in the U.S. below.
Additionally, the ongoing GINECO/ENGOTov25 Phase 3 trial, PAOLA-1, is testing the effect of LYNPARZA in combination with bevacizumab as a first-line maintenance treatment in women with newly diagnosed advanced ovarian cancer, regardless of their BRCA status. Results are expected in 2019.
Indications for LYNPARZA® (olaparib) 100 mg in the U.S.
LYNPARZA 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 complete or partial response to platinum-based chemotherapy.
For the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer who have been treated with 3 or more prior lines of chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.
In patients with deleterious or suspected deleterious gBRCAm,human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine treatment. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.
About SOLO-1
SOLO-1 is a Phase 3 randomized, double-blinded, placebo-controlled, multi-center trial to evaluate the efficacy and safety of LYNPARZA tablets as first-line maintenance monotherapy compared with placebo, in patients with BRCA-mutated (BRCAm) advanced ovarian cancer. The trial randomized 391 patients with a deleterious or suspected deleterious BRCA1 or BRCA2 mutation who were in clinical complete or partial response following platinum-based chemotherapy. Eligible patients were randomized (2:1) to receive LYNPARZA 300 mg tablets twice daily or placebo tablets twice daily. The primary endpoint was progression-free survival (PFS) and key secondary endpoints included time to second disease progression or death (PFS2) and overall survival (OS).
About Ovarian Cancer
Worldwide, ovarian cancer is the seventh most common cancer and the eighth leading cause of cancer death in women. The five-year survival rate for ovarian cancer worldwide is 30-40 percent. In 2012, there were nearly 239,000 new cases diagnosed and around 152,000 deaths.
Approximately 20,000 women in the United States are diagnosed with ovarian cancer (including ovarian, fallopian tube and primary peritoneal cancers) each year. Among women in the United States, it is the ninth most common cancer and the fifth leading cause of cancer death.
The risk of developing ovarian cancer is increased in women with specific inherited genetic abnormalities, including BRCA mutations.
For newly-diagnosed, advanced ovarian cancer, the primary aim of treatment is to delay progression of the disease for as long as possible and maintain the patient’s quality of life, with the intent of achieving complete remission or cure.
About BRCA Mutations
BRCA1 and BRCA2 are human genes that produce proteins responsible for repairing damaged DNA and play an important role in maintaining the genetic stability of cells. When either of these genes is mutated, or altered, such that its protein product either is not made or does not function correctly, DNA damage may not be repaired properly and cells become unstable. As a result, cells are more likely to develop additional genetic alterations that can lead to cancer.
About LYNPARZA
LYNPARZA was the first-in-class PARP inhibitor and the first targeted treatment to potentially exploit DNA damage response (DDR) pathway deficiencies, such as BRCA mutations, to preferentially kill cancer cells. Specifically, in vitro studies have shown that LYNPARZA-induced cytotoxicity may involve inhibition of PARP-enzymatic activity and increased formation of PARP-DNA complexes, resulting in DNA damage and cancer cell death. LYNPARZA is being tested in a range of DDR-deficient tumor types.
LYNPARZA, which is being jointly developed and commercialized by AstraZeneca and Merck, is approved for advanced ovarian cancer and metastatic breast cancer and has been used in over 20,000 patients worldwide. LYNPARZA has a broad and advanced clinical trial development program, and AstraZeneca and Merck are working together to deliver it as quickly as possible to more patients across multiple cancer types.
About the AstraZeneca and Merck Strategic Oncology Collaboration
In July 2017, AstraZeneca and Merck, known as MSD outside the United States and Canada, announced a global strategic oncology collaboration to co-develop and co-commercialize LYNPARZA, the world’s first PARP inhibitor, and potential new medicine selumetinib, a MEK inhibitor, for multiple cancer types. Working together, the companies will develop LYNPARZA and selumetinib in combination with other potential new medicines and as monotherapies. Independently, the companies will develop LYNPARZA and selumetinib in combination with their respective PD-L1 and PD-1 medicines.
Merck’s Focus on Cancer
Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck, the potential to bring new hope to people with cancer drives our purpose and supporting accessibility to our cancer medicines is our commitment.
As part of our focus on cancer, Merck is committed to exploring the potential of immuno-oncology with one of the largest development programs in the industry across more than 30 tumor types. We also continue to strengthen our portfolio through strategic acquisitions and are prioritizing the development of several promising oncology candidates with the potential to improve the treatment of advanced cancers.
For more than a century, Merck, a leading global biopharmaceutical company known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world – including cancer, cardio-metabolic diseases, emerging animal diseases, Alzheimer’s disease and infectious diseases including HIV and Ebola. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.
LYNPARZA Met Primary Endpoint of Progression-Free Survival in Women with BRCA-Mutated Advanced Ovarian Cancer and Showed a Safety Profile Consistent with Previous Trials
AstraZeneca and Merck’s LYNPARZA is the Only PARP Inhibitor to Demonstrate Significant Activity in the First-Line Maintenance Setting
AstraZeneca and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced positive results from the randomized, double-blinded, placebo-controlled, Phase 3 SOLO-1 trial of LYNPARZA® (olaparib) tablets.
Women with BRCA-mutated (BRCAm) advanced ovarian cancer treated first-line with LYNPARZA maintenance therapy had a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to placebo. The safety and tolerability profile of LYNPARZA was consistent with previous trials. Based upon these data, AstraZeneca and Merck plan to initiate discussions with health authorities regarding regulatory submissions.
Sean Bohen, executive vice president, global medicines development and chief medical officer at AstraZeneca, said, “For the first time, we see a significant and clinically impactful improvement in progression-free survival in the first-line maintenance setting for women with BRCA-mutated ovarian cancer treated with a PARP inhibitor. The SOLO-1 data reinforce the importance of knowing BRCA status at diagnosis, as this may enable women with BRCA-mutated ovarian cancer to receive LYNPARZA earlier. We would like to thank the investigators, hospitals and most of all the patients who took part in this trial, without whom medical advancements would not be possible.”
Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said, “Building on the strong data we’ve seen with LYNPARZA to date, the data from SOLO-1 reinforce LYNPARZA’s ability to provide meaningful disease control with a well-characterized safety and tolerability profile. We look forward to presenting the full data set for SOLO-1 at a future medical meeting and working with the regulatory authorities to bring LYNPARZA to women with ovarian cancer in the first-line maintenance setting as quickly as possible.”
LYNPARZA is not currently FDA-approved for 1st-line ovarian maintenance treatment. LYNPARZA is indicated for the maintenance treatment of recurrent ovarian cancer in response to platinum-based chemotherapy regardless of BRCA mutation status, and for the treatment of advanced ovarian cancer patients with a gBRCA-mutation previously treated with three or more lines of chemotherapy. Physicians should select advanced ovarian cancer patients for therapy based on a FDA-approved companion diagnostic. Please see Indications for LYNPARZA® (olaparib) 100 mg in the U.S. below.
Additionally, the ongoing GINECO/ENGOTov25 Phase 3 trial, PAOLA-1, is testing the effect of LYNPARZA in combination with bevacizumab as a first-line maintenance treatment in women with newly diagnosed advanced ovarian cancer, regardless of their BRCA status. Results are expected in 2019.
Indications for LYNPARZA® (olaparib) 100 mg in the U.S.
LYNPARZA 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 complete or partial response to platinum-based chemotherapy.
For the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer who have been treated with 3 or more prior lines of chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.
In patients with deleterious or suspected deleterious gBRCAm,human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine treatment. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.
About SOLO-1
SOLO-1 is a Phase 3 randomized, double-blinded, placebo-controlled, multi-center trial to evaluate the efficacy and safety of LYNPARZA tablets as first-line maintenance monotherapy compared with placebo, in patients with BRCA-mutated (BRCAm) advanced ovarian cancer. The trial randomized 391 patients with a deleterious or suspected deleterious BRCA1 or BRCA2 mutation who were in clinical complete or partial response following platinum-based chemotherapy. Eligible patients were randomized (2:1) to receive LYNPARZA 300 mg tablets twice daily or placebo tablets twice daily. The primary endpoint was progression-free survival (PFS) and key secondary endpoints included time to second disease progression or death (PFS2) and overall survival (OS).
About Ovarian Cancer
Worldwide, ovarian cancer is the seventh most common cancer and the eighth leading cause of cancer death in women. The five-year survival rate for ovarian cancer worldwide is 30-40 percent. In 2012, there were nearly 239,000 new cases diagnosed and around 152,000 deaths.
Approximately 20,000 women in the United States are diagnosed with ovarian cancer (including ovarian, fallopian tube and primary peritoneal cancers) each year. Among women in the United States, it is the ninth most common cancer and the fifth leading cause of cancer death.
The risk of developing ovarian cancer is increased in women with specific inherited genetic abnormalities, including BRCA mutations.
For newly-diagnosed, advanced ovarian cancer, the primary aim of treatment is to delay progression of the disease for as long as possible and maintain the patient’s quality of life, with the intent of achieving complete remission or cure.
About BRCA Mutations
BRCA1 and BRCA2 are human genes that produce proteins responsible for repairing damaged DNA and play an important role in maintaining the genetic stability of cells. When either of these genes is mutated, or altered, such that its protein product either is not made or does not function correctly, DNA damage may not be repaired properly and cells become unstable. As a result, cells are more likely to develop additional genetic alterations that can lead to cancer.
About LYNPARZA
LYNPARZA was the first-in-class PARP inhibitor and the first targeted treatment to potentially exploit DNA damage response (DDR) pathway deficiencies, such as BRCA mutations, to preferentially kill cancer cells. Specifically, in vitro studies have shown that LYNPARZA-induced cytotoxicity may involve inhibition of PARP-enzymatic activity and increased formation of PARP-DNA complexes, resulting in DNA damage and cancer cell death. LYNPARZA is being tested in a range of DDR-deficient tumor types.
LYNPARZA, which is being jointly developed and commercialized by AstraZeneca and Merck, is approved for advanced ovarian cancer and metastatic breast cancer and has been used in over 20,000 patients worldwide. LYNPARZA has a broad and advanced clinical trial development program, and AstraZeneca and Merck are working together to deliver it as quickly as possible to more patients across multiple cancer types.
About the AstraZeneca and Merck Strategic Oncology Collaboration
In July 2017, AstraZeneca and Merck, known as MSD outside the United States and Canada, announced a global strategic oncology collaboration to co-develop and co-commercialize LYNPARZA, the world’s first PARP inhibitor, and potential new medicine selumetinib, a MEK inhibitor, for multiple cancer types. Working together, the companies will develop LYNPARZA and selumetinib in combination with other potential new medicines and as monotherapies. Independently, the companies will develop LYNPARZA and selumetinib in combination with their respective PD-L1 and PD-1 medicines.
Merck’s Focus on Cancer
Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck, the potential to bring new hope to people with cancer drives our purpose and supporting accessibility to our cancer medicines is our commitment.
As part of our focus on cancer, Merck is committed to exploring the potential of immuno-oncology with one of the largest development programs in the industry across more than 30 tumor types. We also continue to strengthen our portfolio through strategic acquisitions and are prioritizing the development of several promising oncology candidates with the potential to improve the treatment of advanced cancers.
For more than a century, Merck, a leading global biopharmaceutical company known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world – including cancer, cardio-metabolic diseases, emerging animal diseases, Alzheimer’s disease and infectious diseases including HIV and Ebola. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.
La Merie Publishing offers an e-mail notification service about the release of new products of La Merie Publishing. This New Product Release Alert also informs about the release of FREE reports produced by La Merie Publishing.
