Merck Wins Early U.S. Approval for Keytruda in Untreated Lung Cancer

Excerpt:

Merck & Co has won U.S. approval to market its immunotherapy Keytruda for use in previously untreated lung cancer patients two months ahead of schedule, making it the only such drug cleared for first-line treatment.

“The green light from the Food and Drug Administration (FDA), announced by the U.S. drugmaker late on Monday, confirms Merck’s leading position in the hot area of medicines that fight tumors by harnessing the body’s immune system.

“Keytruda’s latest approval is for treating first-line metastatic non-small cell lung cancer (NSCLC) in patients with high-levels of a protein called PD-L1, which makes them more receptive to immunotherapy.”

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FDA Approves Atezolizumab for Lung Cancer

Excerpt:

“The FDA has approved atezolizumab (Tecentriq) for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) who have progressed after a platinum-containing regimen and an FDA-approved targeted therapy for those patients harboring EGFR or ALK abnormalities.

“The approval is based on multiple clinical trials, the largest being the phase III OAK trial, which was presented at the 2016 ESMO Congress. In the study, atezolizumab reduced the risk of death by 26% compared with docetaxel in patients with advanced NSCLC following the failure of platinum-based chemotherapy. The median overall survival (OS) was improved by 4.2 months with the PD-L1 inhibitor versus chemotherapy. The survival benefit with atezolizumab was observed regardless of PD-L1 status or histology.”

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Atezolizumab: First PD-L1 Inhibitor for Second-Line NSCLC

Excerpt:

“A slightly different immunotherapy has shown benefit in the second-line treatment of non–small cell lung cancer (NSCLC).

“New data are the first to show that the programmed cell death ligand 1 (PD-L1) atezolizumab (Tecentriq, Genentech/Roche) outperforms chemotherapy in this setting. Hence, it looks set to soon join the two PD inhibitors nivolumab (Opdivo, Bristol-Myers Squibb) and pembrolizumab (Keytruda, Merck & Co) that are already approved for second-line use in NSCLC.”

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Significant Survival Gains with Atezolizumab vs Docetaxel for Non-Small-Cell Lung Cancer

Excerpt:

“The first phase III study of PD-L1 inhibitor atezolizumab in previously-treated non-small-cell lung cancer has seen significant improvements in survival compared to standard chemotherapy, researchers reported at the ESMO 2016 Congress in Copenhagen.

“PD-L1 inhibitors are of a class of cancer immunotherapies called checkpoint inhibitors, and work by inhibiting one of the mechanisms of resistance developed by cancer cells in order to evade the immune system.”

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Pembrolizumab New Option for First Line Treatment of Patients with Advanced Lung Cancer and High PD-L1 Expression

Excerpt:
“Pembrolizumab is set to become a new option for first line treatment of patients with advanced lung cancer and high PD-L1 expression, according to the results of the phase III KEYNOTE-024 trial presented at the ESMO 2016 Congress in Copenhagen and published in the New England Journal of Medicine.

“‘Pembrolizumab is a PD-1 antibody approved for second line treatment of patients with advanced non-small-cell lung cancer (NSCLC) and PD-L1 expression in their tumour cells,’ said lead author Professor Martin Reck, chief oncology physician, Department of Thoracic Oncology, Lung Clinic Grosshansdorf, Germany. ‘KEYNOTE-024 is the first phase III trial of pembrolizumab as first line treatment in patients with high PD-L1 expression, who represent 27-30% of those with advanced NSCLC.’ ”

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Study Characterizes Pneumonitis Risk With Immunotherapeutic Agents

Excerpt:

“Pneumonitis occurs in approximately 5% of cancer patients treated with anti–programmed death 1 (PD-1)/programmed death ligand 1 (PD-L1) immunotherapy agents, according to a new analysis. The complication tends to be low grade and easily resolved, though it can worsen and result in death in rare cases.

“ ‘One of the remarkable characteristics of anti–PD-1/PD-L1 monoclonal antibodies is their relatively mild toxicity profile,’ wrote study authors led by Matthew D. Hellmann, MD, of Memorial Sloan Kettering Cancer Center in New York. ‘However, immune-related adverse events can occur and may be severe.’ Pneumonitis is one such immune-related adverse event, and it accounted for several deaths in early trials of these agents.”

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Rizvi Recounts Recent Immunotherapy Advances in Lung Cancer

Excerpt:

“With frontline pembrolizumab (Keytruda) recently receiving a priority review, immune checkpoint therapy has moved 1 step closer to regulatory approval as a first-line treatment for non–small cell lung cancer (NSCLC).

“The review is based on data from from the phase III KEYNOTE-024 trial, in which frontline pembrolizumab improved overall survival (OS) and progression-free survival (PFS) versus chemotherapy in patients with NSCLC and PD-L1 expression levels ≥50%.”

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Keytruda Receives FDA Breakthrough Therapy Designation, Priority Review for First-Line NSCLC

Excerpt:

“The FDA today granted breakthrough therapy designation and priority review to pembrolizumab for the first-line treatment of patients with advanced non–small cell lung cancer whose tumors express PD-L1, according to the drug’s manufacturer.

“The phase 3 KEYNOTE-024 study — designed to compare pembrolizumab (Keytruda, Merck) monotherapy with standard chemotherapy — included 305 patients with advanced disease.

“All patients’ tumors expressed high levels of PD-L1, defined as a tumor proportion score of 50% or more, and no patients had received prior systemic chemotherapy for their disease.”

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Gradalis®, Inc. Announces Dosing of First Patient in Pilot Study Combining Vigil® Engineered Autologous Tumor Cell Immunotherapy and Durvalumab in Advanced Breast Cancer

Excerpt:

“Gradalis®, Inc., a clinical-stage biopharmaceutical company, today announced that the first patient has been dosed in a pilot study combining Vigil® Engineered Autologous Tumor Cells (EATCs) with durvalumab in advanced breast cancer. This is an open-label, investigator-sponsored study supported partly by a grant from Gradalis, to evaluate the safety, tolerability, and efficacy of the combination of Vigil engineered autologous tumor cell immunotherapy and durvalumab (an investigational human monoclonal antibody directed against programmed death ligand-1 (PD-L1)) in patients with no PD-L1 expression and locally advanced or metastatic triple negative breast cancer (TNBC), that have progressed following two prior lines of therapy.”

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