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Priority Review in NSCLC, Label Update in CLL, Delayed FDA Decision in Lung Cancer, and More

Gina Columbus
Published: Monday, Sep 17, 2018



Today-

A priority review in non–small cell lung cancer, a label update in chronic lymphocytic leukemia, a delayed FDA decision in lung cancer, an ODAC meeting scheduled for a biosimilar, promising findings in renal cell carcinoma, and a European approval in lung cancer.

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

The FDA has granted a priority review to a supplemental biologics license application for single-agent pembrolizumab as a frontline treatment for patients with locally advanced or metastatic nonsquamous or squamous non–small cell lung cancer. The indiciation is specific to patients whose tumors express PD-L1 tumor proportion score greater than 1% without EGFR or ALK alterations.

The decision is based on data from the pivotal phase III KEYNOTE-042 study. Results showed that overall survival with pembrolizumab versus chemotherapy was correlated with greater levels of PD-L1 expression. Those with a tumor proportion score greater than 50% had a median OS of 20 versus 12.2 months, greater than 20% had 17.7 versus 13.0 months, and TPS greater than 1% had an OS of 16.7 versus 12.1 months.

Across all patients with PD-L1 TPS of 1% to 49%, which was an exploratory analysis, the median OS was 13.4 months with pembrolizumab compared with 12.1 months for chemotherapy.

Under the Prescription Drug User Fee Act, the FDA must decide on the application by January 11, 2019.

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In chronic lymphocytic leukemia, the FDA has added minimal residual disease data from the phase III MURANO trial to the label for venetoclax for its approved use in combination with rituximab for previously treated patients with chronic lymphocytic leukemia.

In MURANO, the MRD-negativity rate was 53% following 9 months of treatment with venetoclax plus rituximab versus 12% in the bendamustine plus rituximab arm. Among patients in the 2 arms who achieved a complete response or CR with incomplete marrow recovery, the MRD-negativity rates were 3% versus 2%, respectively.

In April 2016, the FDA granted an accelerated approval to venetoclax for patients with CLL or small lymphocytic lymphoma harboring a 17p deletion, following at least 1 prior therapy. The FDA converted this to a standard approval in June 2018 for the treatment of patients with CLL/SLL, with or without 17p deletion, following at least 1 prior therapy. The FDA simultaneously approved venetoclax for use in combination with rituximab in the same patient population.

The FDA action was based on the overall data from MURANO, in which the median progression-free survival at 23 months' median follow-up was not reached with venetoclax plus rituximab compared with 18.1 months with BR. The overall response rate was 92% versus 72%, respectively.

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The FDA has extended the review period for a supplemental biologics license application for atezolizumab for use in combination with bevacizumab, carboplatin, and paclitaxel for the first-line treatment of patients with metastatic nonsquamous non–small cell lung cancer.

In a news release, Roche, the manufacturer of atezolizumab, reported that the extension will allow ample time for the FDA to review additional information it requested for the application. The new action date for the sBLA is December 5, 2018.

In May 2018, the agency had granted a priority review to the application based on findings from the phase III IMpower150 trial. In the study, the ABCP regimen reduced the risk of death by 22% versus bevacizumab and chemotherapy in patients with advanced wild-type NSCLC.

Results showed that the median overall survival with the addition of the PD-L1 inhibitor atezolizumab was 19.2 months versus 14.7 months in the BCP arm. The 24-month OS rate with atezolizumab was 43% versus 34% for BCP. Moreover, ABCP also improved median progression-free survival by 1.5 months compared with BCP.

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

The FDA has scheduled an Oncologic Drugs Advisory Committee hearing for October 10, 2018, to discuss a biologics license application for CT-P10, a proposed biosimilar to rituximab.

ODAC reviews and evaluates data concerning the safety and effectiveness of investigational human drug products for use in the treatment of cancer and makes recommendations to the FDA.

Data were presented at the 2018 ASCO Annual Meeting for a phase III trial demonstrating noninferiority for frontline CT-P10 compared with rituximab when combining the agents with CVP chemotherapy in patients with advanced-stage follicular lymphoma. Pharmacokinetics, pharmacodynamics, and safety were also comparable between the 2 agents.

CT-P10, which is manufacturered by Celltrion, is currently approved in more than 47 countries.

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

In renal cell carcinoma, phase III results of the JAVELIN Renal 101 study showed that the combination of avelumab with axitinib significantly improved progression-free survival versus sunitinib in treatment-naïve patients with advanced disease.

Data showed that the PFS benefit with the combination was observed regardless of PD-L1 expression levels on patients’ tumors. Pfizer and Merck KGaA, the companies collaborating on the regimen, intend to share data from the trial at an upcoming medical meeting.

The global study randomized 886 patients with advanced RCC to first-line treatment with the combination of avelumab plus axitinib or monotherapy with sunitinib. The primary endpoint was improved PFS or overall survival in those with PD-L1 expression of more than 1%.

The study remains ongoing for the final OS analysis. No new safety signals for the treatments have emerged thus far in the trial.

The FDA granted a breakthrough therapy designation to avelumab with axitinib in December 2017 for use in treatment-naïve patients with advanced RCC. This decision is based on findings from the phase Ib JAVELIN Renal 100 trial. Here, the response rate with the combination was 58.2% in patients with advanced RCC. The complete response rate was 5.5%, the partial response rate was 52.7%, and the disease control rate was 78.2%.

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

In non¬–small cell lung cancer, the European Commission has approved frontline pembrolizumab for use in combination with standard chemotherapy for patients with metastatic nonsquamous disease without EGFR or ALK mutations.

The decision is based on findings from the phase III KEYNOTE-189 trial, in which patients with nonsquamous NSCLC without EGFR or ALK mutations received frontline pembrolizumab or placebo plus pemetrexed and either cisplatin or carboplatin. At a median follow-up of 10.5 months, the estimated 12-month overall survival rate was 69.2% in the pembrolizumab arm compared with 49.4% in the control group.

The median OS was not reached in the pembrolizumab cohort, compared with 11.3 months in the chemotherapy-alone arm. The OS benefit was observed, irrespective of PD-L1 status. The study also met the coprimary endpoint of progression-free survival, with a median PFS of 8.8 months in the pembrolizumab group versus 4.9 months in the control arm.

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

This week, we sat down with Dr Stephen Johnston of The Royal Marsden Hospital to discuss the role of abemaciclib monotherapy in hormone receptor–positive breast cancer.

That’s all for today.

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

A priority review in non–small cell lung cancer, a label update in chronic lymphocytic leukemia, a delayed FDA decision in lung cancer, an ODAC meeting scheduled for a biosimilar, promising findings in renal cell carcinoma, and a European approval in lung cancer.

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

The FDA has granted a priority review to a supplemental biologics license application for single-agent pembrolizumab as a frontline treatment for patients with locally advanced or metastatic nonsquamous or squamous non–small cell lung cancer. The indiciation is specific to patients whose tumors express PD-L1 tumor proportion score greater than 1% without EGFR or ALK alterations.

The decision is based on data from the pivotal phase III KEYNOTE-042 study. Results showed that overall survival with pembrolizumab versus chemotherapy was correlated with greater levels of PD-L1 expression. Those with a tumor proportion score greater than 50% had a median OS of 20 versus 12.2 months, greater than 20% had 17.7 versus 13.0 months, and TPS greater than 1% had an OS of 16.7 versus 12.1 months.

Across all patients with PD-L1 TPS of 1% to 49%, which was an exploratory analysis, the median OS was 13.4 months with pembrolizumab compared with 12.1 months for chemotherapy.

Under the Prescription Drug User Fee Act, the FDA must decide on the application by January 11, 2019.

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

In chronic lymphocytic leukemia, the FDA has added minimal residual disease data from the phase III MURANO trial to the label for venetoclax for its approved use in combination with rituximab for previously treated patients with chronic lymphocytic leukemia.

In MURANO, the MRD-negativity rate was 53% following 9 months of treatment with venetoclax plus rituximab versus 12% in the bendamustine plus rituximab arm. Among patients in the 2 arms who achieved a complete response or CR with incomplete marrow recovery, the MRD-negativity rates were 3% versus 2%, respectively.

In April 2016, the FDA granted an accelerated approval to venetoclax for patients with CLL or small lymphocytic lymphoma harboring a 17p deletion, following at least 1 prior therapy. The FDA converted this to a standard approval in June 2018 for the treatment of patients with CLL/SLL, with or without 17p deletion, following at least 1 prior therapy. The FDA simultaneously approved venetoclax for use in combination with rituximab in the same patient population.

The FDA action was based on the overall data from MURANO, in which the median progression-free survival at 23 months' median follow-up was not reached with venetoclax plus rituximab compared with 18.1 months with BR. The overall response rate was 92% versus 72%, respectively.

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

The FDA has extended the review period for a supplemental biologics license application for atezolizumab for use in combination with bevacizumab, carboplatin, and paclitaxel for the first-line treatment of patients with metastatic nonsquamous non–small cell lung cancer.

In a news release, Roche, the manufacturer of atezolizumab, reported that the extension will allow ample time for the FDA to review additional information it requested for the application. The new action date for the sBLA is December 5, 2018.

In May 2018, the agency had granted a priority review to the application based on findings from the phase III IMpower150 trial. In the study, the ABCP regimen reduced the risk of death by 22% versus bevacizumab and chemotherapy in patients with advanced wild-type NSCLC.

Results showed that the median overall survival with the addition of the PD-L1 inhibitor atezolizumab was 19.2 months versus 14.7 months in the BCP arm. The 24-month OS rate with atezolizumab was 43% versus 34% for BCP. Moreover, ABCP also improved median progression-free survival by 1.5 months compared with BCP.

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

The FDA has scheduled an Oncologic Drugs Advisory Committee hearing for October 10, 2018, to discuss a biologics license application for CT-P10, a proposed biosimilar to rituximab.

ODAC reviews and evaluates data concerning the safety and effectiveness of investigational human drug products for use in the treatment of cancer and makes recommendations to the FDA.

Data were presented at the 2018 ASCO Annual Meeting for a phase III trial demonstrating noninferiority for frontline CT-P10 compared with rituximab when combining the agents with CVP chemotherapy in patients with advanced-stage follicular lymphoma. Pharmacokinetics, pharmacodynamics, and safety were also comparable between the 2 agents.

CT-P10, which is manufacturered by Celltrion, is currently approved in more than 47 countries.

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

In renal cell carcinoma, phase III results of the JAVELIN Renal 101 study showed that the combination of avelumab with axitinib significantly improved progression-free survival versus sunitinib in treatment-naïve patients with advanced disease.

Data showed that the PFS benefit with the combination was observed regardless of PD-L1 expression levels on patients’ tumors. Pfizer and Merck KGaA, the companies collaborating on the regimen, intend to share data from the trial at an upcoming medical meeting.

The global study randomized 886 patients with advanced RCC to first-line treatment with the combination of avelumab plus axitinib or monotherapy with sunitinib. The primary endpoint was improved PFS or overall survival in those with PD-L1 expression of more than 1%.

The study remains ongoing for the final OS analysis. No new safety signals for the treatments have emerged thus far in the trial.

The FDA granted a breakthrough therapy designation to avelumab with axitinib in December 2017 for use in treatment-naïve patients with advanced RCC. This decision is based on findings from the phase Ib JAVELIN Renal 100 trial. Here, the response rate with the combination was 58.2% in patients with advanced RCC. The complete response rate was 5.5%, the partial response rate was 52.7%, and the disease control rate was 78.2%.

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

In non¬–small cell lung cancer, the European Commission has approved frontline pembrolizumab for use in combination with standard chemotherapy for patients with metastatic nonsquamous disease without EGFR or ALK mutations.

The decision is based on findings from the phase III KEYNOTE-189 trial, in which patients with nonsquamous NSCLC without EGFR or ALK mutations received frontline pembrolizumab or placebo plus pemetrexed and either cisplatin or carboplatin. At a median follow-up of 10.5 months, the estimated 12-month overall survival rate was 69.2% in the pembrolizumab arm compared with 49.4% in the control group.

The median OS was not reached in the pembrolizumab cohort, compared with 11.3 months in the chemotherapy-alone arm. The OS benefit was observed, irrespective of PD-L1 status. The study also met the coprimary endpoint of progression-free survival, with a median PFS of 8.8 months in the pembrolizumab group versus 4.9 months in the control arm.

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

This week, we sat down with Dr Stephen Johnston of The Royal Marsden Hospital to discuss the role of abemaciclib monotherapy in hormone receptor–positive breast cancer.

That’s all for today.

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