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FDA Approvals in Ovarian Cancer, Merkel Cell Carcinoma, ITP, and More

Gina Columbus
Published: Thursday, Dec 27, 2018



Today-

FDA approvals in ovarian cancer, Merkel cell carcinoma, immune thrombocytopenia, and of a biosimilar, and a European approval in melanoma.

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

The FDA has approved olaparib as a maintenance treatment for patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to frontline platinum-based chemotherapy. This is the first approval for a PARP inhibitor in the first-line maintenance setting.

The agency also approved BRACAnalysis CDx, a companion diagnostic assay to be used by healthcare professionals to identify patients with advanced ovarian cancer with a germline BRCA mutation and are eligible for first-line maintenance therapy with olaparib in this setting.

The olaparib approval is based on findings from the phase III SOLO-1 trial, in which olaparib reduced the risk of disease progression or death by 70% in patients with BRCA-mutant advanced ovarian cancer who were in complete or partial response to platinum-based chemotherapy compared with placebo following platinum-based chemotherapy. The safety profile of olaparib was consistent with previous trials.

Additionally, at a median follow-up of 41 months, the median progression-free survival by independent central review was not reached in the olaparib arm versus 14.1 months in the placebo arm. The investigator-assessed PFS in the olaparib arm was not reached versus 13.8 months in the placebo arm. The median PFS for olaparib has not yet been reached.

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In Merkel cell carcinoma, the FDA has granted an accelerated approval to pembrolizumab for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic disease.

The approval was based on the phase II CITN-09/KEYNOTE-017 trial, which showed that pembrolizumab elicited an overall response rate per independent review of 56%, as well as a 24% complete response rate and a 32% partial response rate, in patients who did not previously receive systemic therapy.

In the multicenter, single-arm, open-label trial, 50 treatment-naïve patients with recurrent locally advanced or metastatic MCC received pembrolizumab at 2 mg/kg every 3 weeks.

At a median follow-up of 14.9 months, results showed that the median duration of response was not reached. Among the 28 patients with responses, 96% had a DOR greater than 6 months and 54% had a DOR greater than 12 months. Moreover, the median PFS was 16.8 months with pembrolizumab, while the median OS had not been reached.

The accelerated approval of pembrolizumab in this setting is contingent on the results of a confirmatory trial.

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The FDA has approved romiplostim for the treatment of pediatric patients at least 1 year of age with immune thrombocytopenia for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.

The approval is based on 2 double-blind, placebo-controlled trials, the first of which randomized 62 patients with relapsed/refractory disease following at least 1 previous ITP treatment in a 2:1 ratio to either romiplostim or placebo.

Fifty-two percent of patients in the romiplostim arm achieved durable platelet response compared with 10% of the placebo arm. Seventy-one percent versus 20% of patients in the 2 arms had an overall platelet response.

In the second trial, 22 patients were randomized in a 3:1 ratio to romiplostim or placebo. In the romiplostim group, 88% of patients during the treatment period reached a platelet count for 2 consecutive weeks and an increase in platelet count of above baseline for 2 consecutive weeks. Neither outcome measure was reached by any patient treated with placebo.

Overall, romiplostim was well tolerated; 3% of patients discontinued treatment because of AEs.

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

The FDA has granted an approval to the trastuzumab biosimilar CT-P6, known as Herzuma, for the treatment of patients with HER2-overexpressing breast cancer.

The biosimilar is indicated for patients with adjuvant HER2-overexpressing node-positive or -negative breast cancer to be used as part of a treatment regimen comprised of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel, or as part of a regimen with docetaxel and carboplatin.

The biosimilar is also indicated as first-line treatment for patients with HER2-overexpressing metastatic breast cancer to be used in combination with paclitaxel, or as a single agent to treat HER2-positive breast cancer in those who have received 1 or more chemotherapy regimens for metastatic disease.

The decision is based on an extensive review of a comprehensive data package, which included foundational analytical similarity data, nonclinical data, clinical pharmacology, immunogenicity, clinical efficacy, and safety data.

Additionally, 2-year follow-up findings from a double-blind, randomized phase III trial with CT-P6 demonstrated that the biosimilar demonstrated long-term disease-free survival and overall survival that were similar to trastuzumab in the treatment of patients with HER2-positive early breast cancer.

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

In melanoma, the European Commission approved pembrolizumab as an adjuvant therapy for patients with resected, stage III disease with lymph node involvement.

The approval was based on data from the phase III EORTC 1325-MG/KEYNOTE-054 trial. For its review, the European Medicines Agency requested an updated recurrence-free survival analysis with 7 months of additional follow-up beyond the trial’s initial data cutoff. In this analysis, pembrolizumab reduced the risk of disease recurrence or death by 44% versus placebo in patients with resected, high-risk stage III melanoma. The 1-year RFS rates were 76% versus 61%, and the 18-month rates were 72% versus 54%, respectively.

In the United States, the FDA is currently evaluating a supplemental biologics license application for pembrolizumab in this setting based on the previously reported data from the EORTC 1325-MG/KEYNOTE-054 trial. In this earlier analysis, adjuvant pembrolizumab reduced the risk of recurrence or death by 43% in patients with resected, high-risk stage III disease.

At a median follow-up of 15 months, the 1-year RFS rate was 75.4% with the PD-1 inhibitor versus 61.0% with placebo. The RFS benefit was observed regardless of PD-L1 or BRAF mutation status.

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

This week, we sat down with Dr David Maloney, of Fred Hutchinson Cancer Research Center, to discuss post CAR T-cell therapy infusion care and transitioning to outpatient.

That’s all for today.

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

FDA approvals in ovarian cancer, Merkel cell carcinoma, immune thrombocytopenia, and of a biosimilar, and a European approval in melanoma.

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

The FDA has approved olaparib as a maintenance treatment for patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to frontline platinum-based chemotherapy. This is the first approval for a PARP inhibitor in the first-line maintenance setting.

The agency also approved BRACAnalysis CDx, a companion diagnostic assay to be used by healthcare professionals to identify patients with advanced ovarian cancer with a germline BRCA mutation and are eligible for first-line maintenance therapy with olaparib in this setting.

The olaparib approval is based on findings from the phase III SOLO-1 trial, in which olaparib reduced the risk of disease progression or death by 70% in patients with BRCA-mutant advanced ovarian cancer who were in complete or partial response to platinum-based chemotherapy compared with placebo following platinum-based chemotherapy. The safety profile of olaparib was consistent with previous trials.

Additionally, at a median follow-up of 41 months, the median progression-free survival by independent central review was not reached in the olaparib arm versus 14.1 months in the placebo arm. The investigator-assessed PFS in the olaparib arm was not reached versus 13.8 months in the placebo arm. The median PFS for olaparib has not yet been reached.

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

In Merkel cell carcinoma, the FDA has granted an accelerated approval to pembrolizumab for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic disease.

The approval was based on the phase II CITN-09/KEYNOTE-017 trial, which showed that pembrolizumab elicited an overall response rate per independent review of 56%, as well as a 24% complete response rate and a 32% partial response rate, in patients who did not previously receive systemic therapy.

In the multicenter, single-arm, open-label trial, 50 treatment-naïve patients with recurrent locally advanced or metastatic MCC received pembrolizumab at 2 mg/kg every 3 weeks.

At a median follow-up of 14.9 months, results showed that the median duration of response was not reached. Among the 28 patients with responses, 96% had a DOR greater than 6 months and 54% had a DOR greater than 12 months. Moreover, the median PFS was 16.8 months with pembrolizumab, while the median OS had not been reached.

The accelerated approval of pembrolizumab in this setting is contingent on the results of a confirmatory trial.

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

The FDA has approved romiplostim for the treatment of pediatric patients at least 1 year of age with immune thrombocytopenia for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.

The approval is based on 2 double-blind, placebo-controlled trials, the first of which randomized 62 patients with relapsed/refractory disease following at least 1 previous ITP treatment in a 2:1 ratio to either romiplostim or placebo.

Fifty-two percent of patients in the romiplostim arm achieved durable platelet response compared with 10% of the placebo arm. Seventy-one percent versus 20% of patients in the 2 arms had an overall platelet response.

In the second trial, 22 patients were randomized in a 3:1 ratio to romiplostim or placebo. In the romiplostim group, 88% of patients during the treatment period reached a platelet count for 2 consecutive weeks and an increase in platelet count of above baseline for 2 consecutive weeks. Neither outcome measure was reached by any patient treated with placebo.

Overall, romiplostim was well tolerated; 3% of patients discontinued treatment because of AEs.

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

The FDA has granted an approval to the trastuzumab biosimilar CT-P6, known as Herzuma, for the treatment of patients with HER2-overexpressing breast cancer.

The biosimilar is indicated for patients with adjuvant HER2-overexpressing node-positive or -negative breast cancer to be used as part of a treatment regimen comprised of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel, or as part of a regimen with docetaxel and carboplatin.

The biosimilar is also indicated as first-line treatment for patients with HER2-overexpressing metastatic breast cancer to be used in combination with paclitaxel, or as a single agent to treat HER2-positive breast cancer in those who have received 1 or more chemotherapy regimens for metastatic disease.

The decision is based on an extensive review of a comprehensive data package, which included foundational analytical similarity data, nonclinical data, clinical pharmacology, immunogenicity, clinical efficacy, and safety data.

Additionally, 2-year follow-up findings from a double-blind, randomized phase III trial with CT-P6 demonstrated that the biosimilar demonstrated long-term disease-free survival and overall survival that were similar to trastuzumab in the treatment of patients with HER2-positive early breast cancer.

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

In melanoma, the European Commission approved pembrolizumab as an adjuvant therapy for patients with resected, stage III disease with lymph node involvement.

The approval was based on data from the phase III EORTC 1325-MG/KEYNOTE-054 trial. For its review, the European Medicines Agency requested an updated recurrence-free survival analysis with 7 months of additional follow-up beyond the trial’s initial data cutoff. In this analysis, pembrolizumab reduced the risk of disease recurrence or death by 44% versus placebo in patients with resected, high-risk stage III melanoma. The 1-year RFS rates were 76% versus 61%, and the 18-month rates were 72% versus 54%, respectively.

In the United States, the FDA is currently evaluating a supplemental biologics license application for pembrolizumab in this setting based on the previously reported data from the EORTC 1325-MG/KEYNOTE-054 trial. In this earlier analysis, adjuvant pembrolizumab reduced the risk of recurrence or death by 43% in patients with resected, high-risk stage III disease.

At a median follow-up of 15 months, the 1-year RFS rate was 75.4% with the PD-1 inhibitor versus 61.0% with placebo. The RFS benefit was observed regardless of PD-L1 or BRAF mutation status.

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

This week, we sat down with Dr David Maloney, of Fred Hutchinson Cancer Research Center, to discuss post CAR T-cell therapy infusion care and transitioning to outpatient.

That’s all for today.

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