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FDA Approvals in ALL, Ovarian Cancer, Priority Review in CTCL, and sNDA Submitted in RCC

Gina Columbus
Published: Friday, Aug 18, 2017



Today-

FDA approvals in acute lymphoblastic leukemia and ovarian cancer, a priority review designation in cutaneous T-cell lymphoma, a supplemental new drug application in renal cell carcinoma, and results from a phase III kidney cancer trial.

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

The FDA has approved inotuzumab ozogamicin for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. The approval comes with a boxed warning for hepatotoxicity and warning of an increased risk of death following certain types of stem cell transplant.

The decision is based on the first 218 selected patients from the primary analysis of the phase III INO-VATE trial. In these patients, the complete remission rate was 35.8% in the inotuzumab ozogamicin arm compared with 17.4% with chemotherapy.

Of those who achieved a complete remission, 89.7% in the inotuzumab ozogamicin arm were negative for minimal residual disease versus 31.6% with chemotherapy.

Survival was analyzed in all of the enrolled 326 patients. During this review, the risk of progression or death was reduced by 55% with inotuzumab ozogamicin versus standard therapy. Overall survival was improved with inotuzumab ozogamicin versus chemotherapy, but this improvement was not found to be statistically significant.

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The FDA has approved olaparib tablets as a maintenance therapy for patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy, regardless of BRCA status.

The approval was based on data from the phase III SOLO2 trial and the phase II Study 19 trial. In SOLO2, maintenance treatment with olaparib showed a 70% reduction in the risk of progression or death versus placebo for patients with platinum-sensitive, relapsed, BRCA-mutant ovarian cancer. In Study 19, the risk of progression or death was reduced by 65% with maintenance olaparib versus placebo for women with ovarian cancer, regardless of BRCA status.

The FDA noted that the olaparib tablets and capsules were not interchangeable, and that the capsules were being phased out of the US market.

The agency added that olaparib capsules will now only be available through the Lynparza Specialty Pharmacy Network. The capsule formulation of olaparib was approved in 2014 for the treatment of women with BRCA-positive advanced ovarian cancer following treatment with 3 or more prior lines of chemotherapy.

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The FDA has granted a priority review to a supplemental biologics license application for brentuximab vedotin for the treatment of patients with cutaneous T-cell lymphoma.

The application is primarily based on the phase III ALCANZA trial, in which the antibody-drug conjugate induced responses lasting at least 4 months in 56.3% of patients versus 12.5% in patients receiving physician’s choice of standard therapies.

The international, open-label ALCANZA trial included 131 patients with CD30-expressing mycosis fungoides or primary cutaneous anaplastic large cell lymphoma, which are the 2 most common subtypes of CTCL.

At a median follow-up of 22.9 months, the median progression-free survival was 16.7 months with brentuximab vedotin versus 3.5 months with physician’s choice.

The overall response rate was 67% versus 20%, with complete response rates of 16% versus 2%, in the brentuximab vedotin and control arms, respectively. Symptom reduction, as measured by Skindex-29, was significantly better with brentuximab vedotin versus physician’s choice.

Under the Prescription Drug User Fee Act, the FDA is scheduled to make a final approval decision on or before December 16, 2017.

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In renal cell carcinoma, a supplemental new drug application for cabozantinib has been submitted to the FDA for previously untreated patients with renal cell carcinoma.

The decision is based on findings from the phase II CABOSUN trial, in which cabozantinib reduced the risk of progression or death by 34% versus sunitinib as a first-line treatment for patients with metastatic RCC.

Results showed that the median progression-free survival with cabozantinib was 8.2 months versus 5.6 months with sunitinib. Median overall survival was 30.3 months in the cabozantinib arm versus 21.8 months in the sunitinib arm. Cabozantinib was also superior for overall response rate, at 46% versus 18%.

Patients in the cabozantinib arm were more likely to require dose reductions at 58% versus 49%. There were 16 adverse event-related discontinuations in each arm.

Currently, cabozantinib is FDA approved as a treatment for patients with advanced RCC who have received prior antiangiogenic therapy.

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

Also in renal cell carcinoma, topline results from the phase III CheckMate-214 trial showed that the combination of nivolumab and ipilimumab improved the objective response rate and duration of response versus sunitinib in patients with treatment-naïve metastatic disease.

Bristol-Myers Squibb, the manufacturer of both agents, announced the findings in a press release. The combination of the PD-1 inhibitor nivolumab and the CTLA-4 inhibitor ipilimumab met the coprimary endpoint of ORR versus sunitinib, at 41.6% versus 26.5%.

Additionally, the median duration of response was 18.17 months in the sunitinib group. Patients in the combination arm had not yet reached the median duration of response.

The median progression-free survival was 11.56 months for the combination versus 8.38 months for sunitinib, but investigators reported that the difference was not statistically significant.

The study will continue as planned to allow the third coprimary endpoint of overall survival to mature. The company plans to release full results at a future medical meeting.

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

This week, we sat down with Dr William Gradishar of the Feinberg School of Medicine at Northwestern University to discuss emerging agents in the field of HER2-positive breast cancer.

That’s all for today.

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

FDA approvals in acute lymphoblastic leukemia and ovarian cancer, a priority review designation in cutaneous T-cell lymphoma, a supplemental new drug application in renal cell carcinoma, and results from a phase III kidney cancer trial.

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

The FDA has approved inotuzumab ozogamicin for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. The approval comes with a boxed warning for hepatotoxicity and warning of an increased risk of death following certain types of stem cell transplant.

The decision is based on the first 218 selected patients from the primary analysis of the phase III INO-VATE trial. In these patients, the complete remission rate was 35.8% in the inotuzumab ozogamicin arm compared with 17.4% with chemotherapy.

Of those who achieved a complete remission, 89.7% in the inotuzumab ozogamicin arm were negative for minimal residual disease versus 31.6% with chemotherapy.

Survival was analyzed in all of the enrolled 326 patients. During this review, the risk of progression or death was reduced by 55% with inotuzumab ozogamicin versus standard therapy. Overall survival was improved with inotuzumab ozogamicin versus chemotherapy, but this improvement was not found to be statistically significant.

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

The FDA has approved olaparib tablets as a maintenance therapy for patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy, regardless of BRCA status.

The approval was based on data from the phase III SOLO2 trial and the phase II Study 19 trial. In SOLO2, maintenance treatment with olaparib showed a 70% reduction in the risk of progression or death versus placebo for patients with platinum-sensitive, relapsed, BRCA-mutant ovarian cancer. In Study 19, the risk of progression or death was reduced by 65% with maintenance olaparib versus placebo for women with ovarian cancer, regardless of BRCA status.

The FDA noted that the olaparib tablets and capsules were not interchangeable, and that the capsules were being phased out of the US market.

The agency added that olaparib capsules will now only be available through the Lynparza Specialty Pharmacy Network. The capsule formulation of olaparib was approved in 2014 for the treatment of women with BRCA-positive advanced ovarian cancer following treatment with 3 or more prior lines of chemotherapy.

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

The FDA has granted a priority review to a supplemental biologics license application for brentuximab vedotin for the treatment of patients with cutaneous T-cell lymphoma.

The application is primarily based on the phase III ALCANZA trial, in which the antibody-drug conjugate induced responses lasting at least 4 months in 56.3% of patients versus 12.5% in patients receiving physician’s choice of standard therapies.

The international, open-label ALCANZA trial included 131 patients with CD30-expressing mycosis fungoides or primary cutaneous anaplastic large cell lymphoma, which are the 2 most common subtypes of CTCL.

At a median follow-up of 22.9 months, the median progression-free survival was 16.7 months with brentuximab vedotin versus 3.5 months with physician’s choice.

The overall response rate was 67% versus 20%, with complete response rates of 16% versus 2%, in the brentuximab vedotin and control arms, respectively. Symptom reduction, as measured by Skindex-29, was significantly better with brentuximab vedotin versus physician’s choice.

Under the Prescription Drug User Fee Act, the FDA is scheduled to make a final approval decision on or before December 16, 2017.

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

In renal cell carcinoma, a supplemental new drug application for cabozantinib has been submitted to the FDA for previously untreated patients with renal cell carcinoma.

The decision is based on findings from the phase II CABOSUN trial, in which cabozantinib reduced the risk of progression or death by 34% versus sunitinib as a first-line treatment for patients with metastatic RCC.

Results showed that the median progression-free survival with cabozantinib was 8.2 months versus 5.6 months with sunitinib. Median overall survival was 30.3 months in the cabozantinib arm versus 21.8 months in the sunitinib arm. Cabozantinib was also superior for overall response rate, at 46% versus 18%.

Patients in the cabozantinib arm were more likely to require dose reductions at 58% versus 49%. There were 16 adverse event-related discontinuations in each arm.

Currently, cabozantinib is FDA approved as a treatment for patients with advanced RCC who have received prior antiangiogenic therapy.

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

Also in renal cell carcinoma, topline results from the phase III CheckMate-214 trial showed that the combination of nivolumab and ipilimumab improved the objective response rate and duration of response versus sunitinib in patients with treatment-naïve metastatic disease.

Bristol-Myers Squibb, the manufacturer of both agents, announced the findings in a press release. The combination of the PD-1 inhibitor nivolumab and the CTLA-4 inhibitor ipilimumab met the coprimary endpoint of ORR versus sunitinib, at 41.6% versus 26.5%.

Additionally, the median duration of response was 18.17 months in the sunitinib group. Patients in the combination arm had not yet reached the median duration of response.

The median progression-free survival was 11.56 months for the combination versus 8.38 months for sunitinib, but investigators reported that the difference was not statistically significant.

The study will continue as planned to allow the third coprimary endpoint of overall survival to mature. The company plans to release full results at a future medical meeting.

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

This week, we sat down with Dr William Gradishar of the Feinberg School of Medicine at Northwestern University to discuss emerging agents in the field of HER2-positive breast cancer.

That’s all for today.

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