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FDA Approvals of a Biosimilar and DTC Genetic Test, Breakthrough Designation in MZL, and More

Gina Columbus
Published: Friday, Jan 25, 2019



Today-

FDA approvals of a biosimilar and a direct-to-consumer genetic test, a breakthrough designation in marginal zone lymphoma, a complete response letter in triple-negative breast cancer, and supplemental biologics license application in multiple myeloma and non–small cell lung cancer.

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

The FDA has granted an approval to the trastuzumab biosimilar SB3, known by the trade name Ontruzant, for the treatment of patients with HER2-overexpressing breast cancer or metastatic gastric or gastroesophageal junction adenocarcinoma.

The decision is based on data sets from 7 trials that demonstrated similarity in survival outcomes and safety between SB3 and trastuzumab in patients with HER2-positive adjuvant and metastatic breast cancer, as well as HER2-positive metastatic gastric cancer.

Phase III data on the biosimilar showed that it elicited a rate of breast pathologic complete response similar to trastuzumab in patients with HER2-positive breast cancer. Results also demonstrated comparable safety outcomes.

In the per-protocol population, 51.7% of patients achieved bpCR with SB3 versus 42.0% with trastuzumab. The adjusted bpCR ratio was 1.259, which was within the predefined equivalence margins.

In the intent-to-treat population, the bpCR rate was 49.0% in the SB3 arm and 39.7% in the trastuzumab arm. The adjusted ratio of the bpCR rate was 1.243, and the adjusted difference in the bpCR rate was 9.59%.

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The FDA has cleared a direct-to-consumer genetic test for a risk report on MUTYH-associated polyposis, a hereditary colorectal cancer syndrome, manufactured by the personal genetics company 23andMe.

The approval will allow the company to report on the 2 most common genetic variants that influence MUTYH-associated polyposis. Upon its release, the test will be offered to new and existing customers of Health and Ancestry Service. The MUTYH-Associated Polyposis Genetic Health Risk report included at least a 99% accuracy and utilization of key informational concepts that achieved 90% or greater comprehension in a demographically diverse population.

This decision follows the FDA’s March 2018 authorization for 23andMe’s BRCA1/BRCA2 Selected Variants Genetic Health Risk report, which tests 3 selected variants in the BRCA1 and BRCA2 genes.

Similar to the BRCA1/BRCA2 report, customers of the service must choose whether or not they want to receive this information. The report will also include an education module with information on the risk report, its limitations, and how to interpret the results.

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In marginal zone lymphoma, the FDA granted umbralisib a breakthrough therapy designation for the treatment of adult patients who have received 1 prior anti-CD20 regimen.

The designation is based on interim data from a cohort of the ongoing, registration-directed phase II UNITY-NHL trial that is evaluating the PI3K-delta inhibitor as a single agent in patients with MZL.

The phase IIb UNITY-NHL clinical trial is investigating umbralisib as monotherapy or as part of a doublet or a triplet in patients across a number of relapsed/refractory NHL subtypes. The doublet includes the CD20-targeted monoclonal antibody ublituximab, while the triplet includes ublituximab and bendamustine.

The trial is enrolling patients with diffuse large B-cell lymphoma, follicular lymphoma, small lymphocytic lymphoma, and MZL. Umbralisib is being tested as monotherapy in FL, SLL, and MZL, while the DLBCL subtype is being treated with doublet or triplet therapy.

Prior data demonstrated promising outcomes with umbralisib monotherapy and in combination with ublituximab and pembrolizumab in patients with relapsed/refracotory chronic lymphocytic leukemia.

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

The FDA has issued a complete response letter to Immunomedics regarding its biologics license application for sacituzumab govitecan as a treatment for patients with metastatic triple-negative breast cancer who have received at least 2 prior therapies, citing chemistry, manufacturing, and control matters.

Previously, the agency granted a priority review designation to the application for sacituzumab govitecan in July 2018 and was scheduled to make its decision by January 18, 2019.

The application was based on phase II findings, which demonstrated that the antibody-drug conjugate elicited an objective response rate of 34% in patients with heavily pretreated mTNBC .

Additionally, the ORR was accompanied by stable disease for at least 6 months in 11% of patients, for an overall disease control rate of 45%. The median progression-free survival with sacituzumab govitecan was 5.5 months and the median overall survival was 12.7 months.

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

In non–small cell lung cancer, the FDA accepted a supplemental biologics license application for atezolizumab, carboplatin, and nab-paclitaxel as a first-line treatment for patients with metastatic nonsquamous disease.

The application is based on data from the phase III IMpower130 trial, which demonstrated a statistically significant improvement in both progression-free and overall survival versus chemotherapy alone in patients with stage IV nonsquamous NSCLC. The agency is expected to make a decision on the approval by September 2, 2019.

The interim findings showed that the atezolizumab arm was superior in overall survival in the intent-to-treat-wild-type population. Here, the median OS was 18.6 months versus 13.9 months with carboplatin/nab-paclitaxel alone. The 1- and 2-year OS rates with atezolizumab were 63.1% and 39.6% versus 55.5% and 30.0% in the carboplatin/nab-paclitaxel arm.

There was also an improvement in progression-free survival with the atezolizumab combination; the median PFS was 7.0 months and 5.5 months for carboplatin/nab-paclitaxel alone. Moreover, the 6- and 12-month PFS rates also favored the atezolizumab arm at 56.1% and 29.1% versus 42.5% and 14.1% with chemotherapy.

The overall response rate and median duration of response was 49.2% and 8.4 months with the atezolizumab regimen versus 31.9% and 6.1 months with chemotherapy.

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

A supplemental biologics license application has been initiated with the FDA for the combination of daratumumab, lenalidomide, and dexamethasone for the treatment of newly diagnosed patients with multiple myeloma who are ineligible for high-dose chemotherapy and autologous stem cell transplant.

The application is based on data from the phase III MAIA study in which the triplet regimen reduced the risk of disease progression or death by 44% versus lenalidomide plus dexamethasone alone in this patient population. At a median follow-up of 28 months, the median progression-free survival had not been reached with DRd compared with 31.9 months in the Rd group. The PFS rate at 30 months was 71% versus 56%, respectively.

Additionally, the overall response rate was 93% with DRd compared with 81% with Rd. The stringent complete response rate, CR rate, and very good partial response rate were all higher with DRd versus Rd. The partial response rate was higher in the Rd versus DRd group at 28% versus 14%, respectively. The minimal residual disease-negative rate was greater than threefold higher with DRd versus Rd at 24% versus 7%, respectively.

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

This week, we sat down with Dr Joyce O'Shaughnessy, MD, of Baylor University Medical Center, to discuss future roles of PARP inhibition in 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 of a biosimilar and a direct-to-consumer genetic test, a breakthrough designation in marginal zone lymphoma, a complete response letter in triple-negative breast cancer, and supplemental biologics license application in multiple myeloma and non–small cell lung cancer.

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

The FDA has granted an approval to the trastuzumab biosimilar SB3, known by the trade name Ontruzant, for the treatment of patients with HER2-overexpressing breast cancer or metastatic gastric or gastroesophageal junction adenocarcinoma.

The decision is based on data sets from 7 trials that demonstrated similarity in survival outcomes and safety between SB3 and trastuzumab in patients with HER2-positive adjuvant and metastatic breast cancer, as well as HER2-positive metastatic gastric cancer.

Phase III data on the biosimilar showed that it elicited a rate of breast pathologic complete response similar to trastuzumab in patients with HER2-positive breast cancer. Results also demonstrated comparable safety outcomes.

In the per-protocol population, 51.7% of patients achieved bpCR with SB3 versus 42.0% with trastuzumab. The adjusted bpCR ratio was 1.259, which was within the predefined equivalence margins.

In the intent-to-treat population, the bpCR rate was 49.0% in the SB3 arm and 39.7% in the trastuzumab arm. The adjusted ratio of the bpCR rate was 1.243, and the adjusted difference in the bpCR rate was 9.59%.

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

The FDA has cleared a direct-to-consumer genetic test for a risk report on MUTYH-associated polyposis, a hereditary colorectal cancer syndrome, manufactured by the personal genetics company 23andMe.

The approval will allow the company to report on the 2 most common genetic variants that influence MUTYH-associated polyposis. Upon its release, the test will be offered to new and existing customers of Health and Ancestry Service. The MUTYH-Associated Polyposis Genetic Health Risk report included at least a 99% accuracy and utilization of key informational concepts that achieved 90% or greater comprehension in a demographically diverse population.

This decision follows the FDA’s March 2018 authorization for 23andMe’s BRCA1/BRCA2 Selected Variants Genetic Health Risk report, which tests 3 selected variants in the BRCA1 and BRCA2 genes.

Similar to the BRCA1/BRCA2 report, customers of the service must choose whether or not they want to receive this information. The report will also include an education module with information on the risk report, its limitations, and how to interpret the results.

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

In marginal zone lymphoma, the FDA granted umbralisib a breakthrough therapy designation for the treatment of adult patients who have received 1 prior anti-CD20 regimen.

The designation is based on interim data from a cohort of the ongoing, registration-directed phase II UNITY-NHL trial that is evaluating the PI3K-delta inhibitor as a single agent in patients with MZL.

The phase IIb UNITY-NHL clinical trial is investigating umbralisib as monotherapy or as part of a doublet or a triplet in patients across a number of relapsed/refractory NHL subtypes. The doublet includes the CD20-targeted monoclonal antibody ublituximab, while the triplet includes ublituximab and bendamustine.

The trial is enrolling patients with diffuse large B-cell lymphoma, follicular lymphoma, small lymphocytic lymphoma, and MZL. Umbralisib is being tested as monotherapy in FL, SLL, and MZL, while the DLBCL subtype is being treated with doublet or triplet therapy.

Prior data demonstrated promising outcomes with umbralisib monotherapy and in combination with ublituximab and pembrolizumab in patients with relapsed/refracotory chronic lymphocytic leukemia.

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

The FDA has issued a complete response letter to Immunomedics regarding its biologics license application for sacituzumab govitecan as a treatment for patients with metastatic triple-negative breast cancer who have received at least 2 prior therapies, citing chemistry, manufacturing, and control matters.

Previously, the agency granted a priority review designation to the application for sacituzumab govitecan in July 2018 and was scheduled to make its decision by January 18, 2019.

The application was based on phase II findings, which demonstrated that the antibody-drug conjugate elicited an objective response rate of 34% in patients with heavily pretreated mTNBC .

Additionally, the ORR was accompanied by stable disease for at least 6 months in 11% of patients, for an overall disease control rate of 45%. The median progression-free survival with sacituzumab govitecan was 5.5 months and the median overall survival was 12.7 months.

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

In non–small cell lung cancer, the FDA accepted a supplemental biologics license application for atezolizumab, carboplatin, and nab-paclitaxel as a first-line treatment for patients with metastatic nonsquamous disease.

The application is based on data from the phase III IMpower130 trial, which demonstrated a statistically significant improvement in both progression-free and overall survival versus chemotherapy alone in patients with stage IV nonsquamous NSCLC. The agency is expected to make a decision on the approval by September 2, 2019.

The interim findings showed that the atezolizumab arm was superior in overall survival in the intent-to-treat-wild-type population. Here, the median OS was 18.6 months versus 13.9 months with carboplatin/nab-paclitaxel alone. The 1- and 2-year OS rates with atezolizumab were 63.1% and 39.6% versus 55.5% and 30.0% in the carboplatin/nab-paclitaxel arm.

There was also an improvement in progression-free survival with the atezolizumab combination; the median PFS was 7.0 months and 5.5 months for carboplatin/nab-paclitaxel alone. Moreover, the 6- and 12-month PFS rates also favored the atezolizumab arm at 56.1% and 29.1% versus 42.5% and 14.1% with chemotherapy.

The overall response rate and median duration of response was 49.2% and 8.4 months with the atezolizumab regimen versus 31.9% and 6.1 months with chemotherapy.

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

A supplemental biologics license application has been initiated with the FDA for the combination of daratumumab, lenalidomide, and dexamethasone for the treatment of newly diagnosed patients with multiple myeloma who are ineligible for high-dose chemotherapy and autologous stem cell transplant.

The application is based on data from the phase III MAIA study in which the triplet regimen reduced the risk of disease progression or death by 44% versus lenalidomide plus dexamethasone alone in this patient population. At a median follow-up of 28 months, the median progression-free survival had not been reached with DRd compared with 31.9 months in the Rd group. The PFS rate at 30 months was 71% versus 56%, respectively.

Additionally, the overall response rate was 93% with DRd compared with 81% with Rd. The stringent complete response rate, CR rate, and very good partial response rate were all higher with DRd versus Rd. The partial response rate was higher in the Rd versus DRd group at 28% versus 14%, respectively. The minimal residual disease-negative rate was greater than threefold higher with DRd versus Rd at 24% versus 7%, respectively.

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

This week, we sat down with Dr Joyce O'Shaughnessy, MD, of Baylor University Medical Center, to discuss future roles of PARP inhibition in breast cancer.

That’s all for today.

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