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FDA Approval in Lung Cancer, Promising Findings in Hodgkin Lymphoma, and More

Gina Columbus
Published Online: Friday, Jun 30, 2017



Today-

An FDA approval in lung cancer, promising findings in Hodgkin lymphoma, a complete response letter issued for a biosimilar, exciting results in multiple myeloma from the 22nd Annual European Hematology Association Congress, and a recommendation for a kidney cancer approval.

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

The FDA has approved the combination of dabrafenib and trametinib for patients with BRAF V600–positive advanced or metastatic non–small cell lung cancer.

In the phase II trial that led to the approval, the overall response rate was 61.1% in patients who were treatment-naïve, and 68% of patients did not show progression at a median follow-up of 9 months. This cohort had not reached endpoints for median duration of response or progression-free survival at the time of approval. However, among patients who responded to treatment, 59% had responses lasting longer than 6 months.

In patients who were previously treated, the ORR was 63%. Researchers found that the response was durable, with a median duration of response of 12.6 months.

The FDA also approved the Oncomine Dx Target Test, a next generation sequencing test that detects the presence of BRAFROS1, and EGFR gene mutations. This is the first NGS oncology panel test the FDA has approved for multiple companion diagnostic indications.

The European Union approved the dabrafenib/trametinib combination in April 2017. 

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In classical Hodgkin lymphoma, phase III findings showed that frontline brentuximab vedotin was associated with improved progression-free survival compared with standard chemotherapy in patients with advanced disease.

Results of the global, multicenter ECHELON-1 trial demonstrated that the 2-year modified PFS rate for brentuximab vedotin plus adriamycin, vinblastine, and dacarbazine was 82.1% versus 77.2% for patients receiving adriamycin, bleomycin, vinblastine, and dacarbazine. The brentuximab vedotin combination reduced the risk of disease progression or death by 23%.

An interim analysis of overall survival also showed a trend favoring the brentuximab arm. More data will be presented this December at the 2017 ASH Annual Meeting.

ECHELON-1 enrolled 1334 patients with a histologically-confirmed diagnosis of stage III or IV classical Hodgkin’s lymphoma who had not been previously treated with systemic chemotherapy or radiotherapy. Study sites included medical facilities on every continent except Antarctica.

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The FDA has rejected a biologics license application for the epoetin alfa biosimilar epoetin hospira. The agency cited manufacturing concerns at the company’s fill-finish facility in McPherson, Kansas.

The decision marks an uncommon situation of the FDA denying a drug recommended by the Oncologic Drugs Advisory Committee, which voted 14 to 1 to approve the BLA on May 25, 2017.

Pfizer, the manufacturer of the biosimilar, received a warning letter from the FDA in February 2017 detailing 5 areas of concern including in-process specifications, failure to follow procedures to prevent microbiological contamination of drug products, and a lack of scientifically sound and appropriate sampling plans for inspection and analytical activities.

Moreover, the FDA argued that Pfizer should have known the McPherson site might have problems since the FDA cited 5 other Hospira plants for similar problems from 2010 to 2015.

Pfizer stressed that none of those issues specifically relate to epoetin hospira, though the McPherson plant was a potential manufacturing site. Additionally, the FDA did not request more data to support a further approval as it did in 2015, when the agency rejected an abbreviated BLA.

Pfizer said it submitted a corrective and preventative action plan to the FDA in March and is working to address the concerns listed in the warning letter.

Hospira was seeking approval to treat anemia due to chronic kidney disease, to treat anemia in HIV-infected patients being treated with zidovudine, to treat chronic renal failure, and to reduce the need for allogeneic red blood cell transfusions in patients with perioperative hemoglobin from more than 10 g/dL to less than 13 g/dL who are at high risk for perioperative blood loss from elective noncardiac, nonvascular surgery.

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

Phase I data presented at the 22nd Annual European Hematology Association Congress demonstrated that patients with multiple myeloma achieved a response following treatment with an active dose of bb2121, an investigational anti–B-cell maturation antigen chimeric antigen receptor T-cell construct.

The objective response rate of the CRB-401 trial was 100% in 9 evaluable patients who had been infused with bb2121 at a dose of 5.0 x 107 CAR-positive T cells or higher; 27% of patients achieved complete response, and 75% of patients demonstrated a very good partial response or better. The evaluable patients at this dose level were minimal residual disease-negative.

Furthermore, the ORR across all dose levels was 89%. The median time to first response was 31 days, and the median time to best response was 50.5 days. The median duration of response was 134 days.

The ongoing study is enrolling at 7 sites to an anticipated total enrollment of 50 patients.

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

The European Medicines Agency’s Committee for Medicinal Products for Human Use granted a positive opinion recommending marketing authorization of tivozanib for adult patients with advanced renal cell carcinoma.

The opinion was based on results from the phase III TiVO-1 trial, which evaluated the efficacy and tolerability of tivozanib compared with sorafenib.

The median progression-free survival in the tivozanib arm was 11.9 months compared with 9.1 months in the sorafenib arm. Additionally, treatment-naïve patients who received tivozanib enjoyed a greater improvement in PFS. For those patients, the median PFS was 12.7 months versus 9.1 months in the sorafenib treatment-naïve arm.

At the time of the overall survival analysis, mortality rates were 45.4% in the tivozanib group and 39.3% in the sorafenib group, corresponding with a stratified hazard ratio of 1.245 trending in favor of sorafenib. The median OS was 28.8 months in the tivozanib arm and 29.3 months in the sorafenib arm.

Should the full committee accept the positive opinion, tivozanib would be approved for use in the 28 European Union member states plus Norway and Iceland to treat adults with advanced RCC who are VEGFR and mTOR pathway inhibitor-naïve and are either untreated or have failed prior therapy with interferon-alpha or interleukin-2.

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

This week, Dr. Richard Boulay of Lehigh Valley Health Network discussed recent advancements in gynecologic malignancies.

That’s all for today.

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

An FDA approval in lung cancer, promising findings in Hodgkin lymphoma, a complete response letter issued for a biosimilar, exciting results in multiple myeloma from the 22nd Annual European Hematology Association Congress, and a recommendation for a kidney cancer approval.

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

The FDA has approved the combination of dabrafenib and trametinib for patients with BRAF V600–positive advanced or metastatic non–small cell lung cancer.

In the phase II trial that led to the approval, the overall response rate was 61.1% in patients who were treatment-naïve, and 68% of patients did not show progression at a median follow-up of 9 months. This cohort had not reached endpoints for median duration of response or progression-free survival at the time of approval. However, among patients who responded to treatment, 59% had responses lasting longer than 6 months.

In patients who were previously treated, the ORR was 63%. Researchers found that the response was durable, with a median duration of response of 12.6 months.

The FDA also approved the Oncomine Dx Target Test, a next generation sequencing test that detects the presence of BRAFROS1, and EGFR gene mutations. This is the first NGS oncology panel test the FDA has approved for multiple companion diagnostic indications.

The European Union approved the dabrafenib/trametinib combination in April 2017. 

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

In classical Hodgkin lymphoma, phase III findings showed that frontline brentuximab vedotin was associated with improved progression-free survival compared with standard chemotherapy in patients with advanced disease.

Results of the global, multicenter ECHELON-1 trial demonstrated that the 2-year modified PFS rate for brentuximab vedotin plus adriamycin, vinblastine, and dacarbazine was 82.1% versus 77.2% for patients receiving adriamycin, bleomycin, vinblastine, and dacarbazine. The brentuximab vedotin combination reduced the risk of disease progression or death by 23%.

An interim analysis of overall survival also showed a trend favoring the brentuximab arm. More data will be presented this December at the 2017 ASH Annual Meeting.

ECHELON-1 enrolled 1334 patients with a histologically-confirmed diagnosis of stage III or IV classical Hodgkin’s lymphoma who had not been previously treated with systemic chemotherapy or radiotherapy. Study sites included medical facilities on every continent except Antarctica.

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

The FDA has rejected a biologics license application for the epoetin alfa biosimilar epoetin hospira. The agency cited manufacturing concerns at the company’s fill-finish facility in McPherson, Kansas.

The decision marks an uncommon situation of the FDA denying a drug recommended by the Oncologic Drugs Advisory Committee, which voted 14 to 1 to approve the BLA on May 25, 2017.

Pfizer, the manufacturer of the biosimilar, received a warning letter from the FDA in February 2017 detailing 5 areas of concern including in-process specifications, failure to follow procedures to prevent microbiological contamination of drug products, and a lack of scientifically sound and appropriate sampling plans for inspection and analytical activities.

Moreover, the FDA argued that Pfizer should have known the McPherson site might have problems since the FDA cited 5 other Hospira plants for similar problems from 2010 to 2015.

Pfizer stressed that none of those issues specifically relate to epoetin hospira, though the McPherson plant was a potential manufacturing site. Additionally, the FDA did not request more data to support a further approval as it did in 2015, when the agency rejected an abbreviated BLA.

Pfizer said it submitted a corrective and preventative action plan to the FDA in March and is working to address the concerns listed in the warning letter.

Hospira was seeking approval to treat anemia due to chronic kidney disease, to treat anemia in HIV-infected patients being treated with zidovudine, to treat chronic renal failure, and to reduce the need for allogeneic red blood cell transfusions in patients with perioperative hemoglobin from more than 10 g/dL to less than 13 g/dL who are at high risk for perioperative blood loss from elective noncardiac, nonvascular surgery.

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

Phase I data presented at the 22nd Annual European Hematology Association Congress demonstrated that patients with multiple myeloma achieved a response following treatment with an active dose of bb2121, an investigational anti–B-cell maturation antigen chimeric antigen receptor T-cell construct.

The objective response rate of the CRB-401 trial was 100% in 9 evaluable patients who had been infused with bb2121 at a dose of 5.0 x 107 CAR-positive T cells or higher; 27% of patients achieved complete response, and 75% of patients demonstrated a very good partial response or better. The evaluable patients at this dose level were minimal residual disease-negative.

Furthermore, the ORR across all dose levels was 89%. The median time to first response was 31 days, and the median time to best response was 50.5 days. The median duration of response was 134 days.

The ongoing study is enrolling at 7 sites to an anticipated total enrollment of 50 patients.

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

The European Medicines Agency’s Committee for Medicinal Products for Human Use granted a positive opinion recommending marketing authorization of tivozanib for adult patients with advanced renal cell carcinoma.

The opinion was based on results from the phase III TiVO-1 trial, which evaluated the efficacy and tolerability of tivozanib compared with sorafenib.

The median progression-free survival in the tivozanib arm was 11.9 months compared with 9.1 months in the sorafenib arm. Additionally, treatment-naïve patients who received tivozanib enjoyed a greater improvement in PFS. For those patients, the median PFS was 12.7 months versus 9.1 months in the sorafenib treatment-naïve arm.

At the time of the overall survival analysis, mortality rates were 45.4% in the tivozanib group and 39.3% in the sorafenib group, corresponding with a stratified hazard ratio of 1.245 trending in favor of sorafenib. The median OS was 28.8 months in the tivozanib arm and 29.3 months in the sorafenib arm.

Should the full committee accept the positive opinion, tivozanib would be approved for use in the 28 European Union member states plus Norway and Iceland to treat adults with advanced RCC who are VEGFR and mTOR pathway inhibitor-naïve and are either untreated or have failed prior therapy with interferon-alpha or interleukin-2.

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

This week, Dr. Richard Boulay of Lehigh Valley Health Network discussed recent advancements in gynecologic malignancies.

That’s all for today.

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