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NDA Withdrawn in Melanoma, Promising Phase III Results in Breast Cancer and Ovarian Cancer, and More

Gina Columbus
Published: Monday, Mar 27, 2017



Today, promising phase III findings in breast cancer and ovarian cancer, a new drug application withdrawn in melanoma, and oncology societies speak out about the potential NIH funding cut.

Welcome to OncLive News Network! I’m Gina Columbus.

In breast cancer, the addition of the CDK4/6 inhibitor abemaciclib to fulvestrant was found to improve progression-free survival versus fulvestrant alone in patients with hormone receptor-positive, HER2-negative disease enrolled in the phase III MONARCH 2 study.

The study randomized 669 patients in a 2:1 ratio to the combination versus fulvestrant alone.

Eli Lilly and Company, the manufacturer of abemaciclib, said that it plans to present the full study results at an upcoming medical meeting and submit the data to the FDA for regulatory review in the third quarter of 2017.

The safety data were consistent with results presented in previous abemaciclib trials, with the most common adverse events being diarrhea, neutropenia, nausea, and fatigue.

The company said that it would also submit an application to the FDA for single-agent abemaciclib based on data from the MONARCH 1 trial, in which abemaciclib monotherapy induced a response rate of nearly 20% in heavily pretreated patients with refractory HR+, HER2-negative advanced breast cancer.

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Phase III trial results showed that maintenance therapy with olaparib led to a 70% reduction in the risk of disease progression or death versus placebo for patients with ovarian cancer that was platinum-sensitive, relapsed, and BRCA-mutant.

The findings were from the phase III SOLO2 study, which were presented earlier this month at the 2017 Society of Gynecologic Oncology Meeting.

In the patients who received olaparib, the median investigator-assessed progression-free survival was 19.1 months versus 5.5 months in the placebo arm. Additionally, a prespecified analysis of PFS by a blinded central review committee showed a median PFS of 30.2 months for the olaparib arm versus 5.5 months for placebo.

The median time to first subsequent therapy, which was a secondary endpoint, was 27.9 months with olaparib versus 7.1 months with placebo. The median PFS2 had yet to be reached with the PARP inhibitor and was 18.4 months with placebo. This led to a 50% reduction in the hazard ratio in favor of olaparib.

The overall survival data are not yet mature.

*****************************************************************************

Array BioPharma, the developer of binimetinib, has withdrawn its new drug application for the MEK inhibitor as a treatment for patients who have NRAS-mutant melanoma.

The application for binimetinib was based on data from the phase III NEMO study, which randomized patients to binimetinib versus dacarbazine.

In the open-label study, the median progression-free survival with binimetinib was 2.8 months versus 1.5 months with dacarbazine, leading to a 38% reduction in the risk of progression or death. However, overall survival was not improved with binimetinib.

The decision was based on feedback from the FDA during a preplanned review meeting, at which the company concluded that the clinical benefit demonstrated in the NEMO trial would not be sufficient for the FDA to approve the treatment for an NRAS-mutant melanoma indication.

In addition to NRAS-mutated tumors, binimetinib was also explored in combination with the BRAF inhibitor encorafenib as a treatment for BRAF-mutant melanoma in the phase III COLUMBUS trial. Here, the median PFS with the combination by independent review was 14.9 months with encorafenib plus binimetinib versus 7.3 months for vemurafenib.

Array noted that the withdrawal of the NRAS-mutant application would not impact the filing of data to the FDA from the COLUMBUS trial. This application is anticipated by the middle of 2017.

*****************************************************************************

Finally, following President Donald Trump’s fiscal year 2018 budget proposal, which calls for a $5.8 billion cut in funding for the National Institutes of Health, oncology societies are speaking out to denounce the plan.

The budget, which was released March 16, was labeled by the President as a blueprint for making America great again. However, various organizations have called it a huge potential setback to health efforts and the fight against cancer.

In a statement, ASCO said that it soundly opposes President Trump’s budget outline, and that reducing NIH’s funding will devastate the nation’s already fragile federal research infrastructure. ASCO also said that it would undercut a longstanding commitment to biomedical science that has fueled advances in cancer prevention, diagnosis, and treatment.

The NIH funding cut is nearly 19%. Through the National Cancer Institute, the NIH supports a significant amount of cancer research, including clinical trials, at independent institutions throughout the country.

The NIH had a fiscal year 2016 budget of $32 billion, and in the yet nonfinalized fiscal year 2017 budget, the agency would receive $34 billion.

President Trump’s budget proposal calls for dramatic cuts in various other types of health spending and is part of his plan to increase military spending by $54 billion next year, largely by drawing from nonmilitary spending.

If this were approved, the budget would leave the NIH with $25.9 billion and would involve a major reorganization of NIH institutes and centers to refocus resources on priority research and training activities.

*****************************************************************************

That’s all for today.

Thank you for watching OncLive News Network! I’m Gina Columbus.
 
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Today, promising phase III findings in breast cancer and ovarian cancer, a new drug application withdrawn in melanoma, and oncology societies speak out about the potential NIH funding cut.

Welcome to OncLive News Network! I’m Gina Columbus.

In breast cancer, the addition of the CDK4/6 inhibitor abemaciclib to fulvestrant was found to improve progression-free survival versus fulvestrant alone in patients with hormone receptor-positive, HER2-negative disease enrolled in the phase III MONARCH 2 study.

The study randomized 669 patients in a 2:1 ratio to the combination versus fulvestrant alone.

Eli Lilly and Company, the manufacturer of abemaciclib, said that it plans to present the full study results at an upcoming medical meeting and submit the data to the FDA for regulatory review in the third quarter of 2017.

The safety data were consistent with results presented in previous abemaciclib trials, with the most common adverse events being diarrhea, neutropenia, nausea, and fatigue.

The company said that it would also submit an application to the FDA for single-agent abemaciclib based on data from the MONARCH 1 trial, in which abemaciclib monotherapy induced a response rate of nearly 20% in heavily pretreated patients with refractory HR+, HER2-negative advanced breast cancer.

*****************************************************************************

Phase III trial results showed that maintenance therapy with olaparib led to a 70% reduction in the risk of disease progression or death versus placebo for patients with ovarian cancer that was platinum-sensitive, relapsed, and BRCA-mutant.

The findings were from the phase III SOLO2 study, which were presented earlier this month at the 2017 Society of Gynecologic Oncology Meeting.

In the patients who received olaparib, the median investigator-assessed progression-free survival was 19.1 months versus 5.5 months in the placebo arm. Additionally, a prespecified analysis of PFS by a blinded central review committee showed a median PFS of 30.2 months for the olaparib arm versus 5.5 months for placebo.

The median time to first subsequent therapy, which was a secondary endpoint, was 27.9 months with olaparib versus 7.1 months with placebo. The median PFS2 had yet to be reached with the PARP inhibitor and was 18.4 months with placebo. This led to a 50% reduction in the hazard ratio in favor of olaparib.

The overall survival data are not yet mature.

*****************************************************************************

Array BioPharma, the developer of binimetinib, has withdrawn its new drug application for the MEK inhibitor as a treatment for patients who have NRAS-mutant melanoma.

The application for binimetinib was based on data from the phase III NEMO study, which randomized patients to binimetinib versus dacarbazine.

In the open-label study, the median progression-free survival with binimetinib was 2.8 months versus 1.5 months with dacarbazine, leading to a 38% reduction in the risk of progression or death. However, overall survival was not improved with binimetinib.

The decision was based on feedback from the FDA during a preplanned review meeting, at which the company concluded that the clinical benefit demonstrated in the NEMO trial would not be sufficient for the FDA to approve the treatment for an NRAS-mutant melanoma indication.

In addition to NRAS-mutated tumors, binimetinib was also explored in combination with the BRAF inhibitor encorafenib as a treatment for BRAF-mutant melanoma in the phase III COLUMBUS trial. Here, the median PFS with the combination by independent review was 14.9 months with encorafenib plus binimetinib versus 7.3 months for vemurafenib.

Array noted that the withdrawal of the NRAS-mutant application would not impact the filing of data to the FDA from the COLUMBUS trial. This application is anticipated by the middle of 2017.

*****************************************************************************

Finally, following President Donald Trump’s fiscal year 2018 budget proposal, which calls for a $5.8 billion cut in funding for the National Institutes of Health, oncology societies are speaking out to denounce the plan.

The budget, which was released March 16, was labeled by the President as a blueprint for making America great again. However, various organizations have called it a huge potential setback to health efforts and the fight against cancer.

In a statement, ASCO said that it soundly opposes President Trump’s budget outline, and that reducing NIH’s funding will devastate the nation’s already fragile federal research infrastructure. ASCO also said that it would undercut a longstanding commitment to biomedical science that has fueled advances in cancer prevention, diagnosis, and treatment.

The NIH funding cut is nearly 19%. Through the National Cancer Institute, the NIH supports a significant amount of cancer research, including clinical trials, at independent institutions throughout the country.

The NIH had a fiscal year 2016 budget of $32 billion, and in the yet nonfinalized fiscal year 2017 budget, the agency would receive $34 billion.

President Trump’s budget proposal calls for dramatic cuts in various other types of health spending and is part of his plan to increase military spending by $54 billion next year, largely by drawing from nonmilitary spending.

If this were approved, the budget would leave the NIH with $25.9 billion and would involve a major reorganization of NIH institutes and centers to refocus resources on priority research and training activities.

*****************************************************************************

That’s all for today.

Thank you for watching OncLive News Network! I’m Gina Columbus.
 
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