FDA Grants Priority Review to Tecentriq Combo for First-Line Treatment of Advanced Lung Cancer

Excerpt:

“The U.S. Food and Drug Administration has granted priority review to Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) and chemotherapy medications Taxol (paclitaxel) and carboplatin for first-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC).

“Priority review of Roche’s supplemental Biologics License Application means the FDA will decide whether or not to approve the therapy within six months instead of the standard 10 months. A decision is now expected by Sept. 5. To be granted priority review, a therapy candidate must show potential to provide significant benefits for the treatment, prevention, or diagnosis of a disease.”

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FDA Grants Priority Review to Tecentriq Combo for First-Line Treatment of Advanced Lung Cancer

Excerpt:

“The U.S. Food and Drug Administration has granted priority review to Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) and chemotherapy medications Taxol (paclitaxel) and carboplatin for first-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC).

“Priority review of Roche’s supplemental Biologics License Application means the FDA will decide whether or not to approve the therapy within six months instead of the standard 10 months. A decision is now expected by Sept. 5. To be granted priority review, a therapy candidate must show potential to provide significant benefits for the treatment, prevention, or diagnosis of a disease.”

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First Line Combination Therapy Improves Progression-Free Survival in Advanced Lung Cancer

Excerpt:

“A new combination therapy for the first line treatment of advanced non-squamous non-small-cell lung cancer (NSCLC) improves progression-free survival (PFS), according to results of the phase III IMpower150 trial presented at the ESMO Immuno Oncology Congress 2017.

” ‘This is the first phase III trial to report on the combination of chemotherapy, antiangiogenic treatment and immunotherapy as first line treatment for advanced non-squamous NSCLC,’ said lead author Professor Martin Reck, chief oncology physician, Department of Thoracic Oncology, Lung Clinic Grosshansdorf, Germany. ‘The trial met its co-primary endpoint of PFS and the preliminary results of the co-primary endpoint of overall survival (OS), although immature, look encouraging.’ ”

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Adding Pemetrexed to Gefitinib Improves PFS in EGFR-Mutated NSCLC

Excerpt:

“The combination of pemetrexed and gefitinib offered improved progression-free survival (PFS) over gefitinib alone in East Asian patients with advanced nonsquamous non–small-cell lung cancer (NSCLC) and activating EGFR mutations, according to a new randomized, open-label study.

“EGFR tyrosine kinase inhibitors (TKIs) including gefitinib have been shown to improve outcomes in patients with EGFR-mutated NSCLC. ‘Given their different mechanisms of action, combination treatment with EGFR-TKIs and chemotherapy may further improve outcomes,’ wrote study authors led by James Chih-Hsin Yang, MD, PhD, of National Taiwan University Hospital in Taipei. Previous trials of such combinations have not shown clinical benefit, however, though this could have been because of antagonism between the agents used or because wild-type EGFR patients were included.”

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Oncolytics Biotech® Inc. Reports Additional Data from Randomized Phase II Study of REOLYSIN® in Non-Small Cell Lung Cancer

Excerpt:

“Oncolytics Biotech Inc. …today announced additional data from IND 211, a randomized, Phase II clinical study of REOLYSIN® in patients with non-small cell lung cancer (“NSCLC”). The study enrolled patients with both non-squamous (adenocarcinoma) and squamous cell histology. Those with adenocarcinoma (n=75) were treated with REOLYSIN® in combination with pemetrexed in the test arm versus pemetrexed alone in the control arm. Those with squamous cell histology (n=76) were treated with REOLYSIN® in combination with docetaxel in the test arm versus docetaxel alone in the control arm. The study’s primary objective was progression free survival (“PFS”). Its secondary objectives included overall survival (“OS”), safety, and measurement of biomarkers that may be predictive of response.”

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Addition of Bevacizumab Shows No Survival Advantage Over Cisplatin Pemetrexed Alone in Non-Squamous NSCLC

Excerpt:

“Preliminary data from the SAKK19/09 trial shows no overall survival difference between two cohorts of patients with non-squamous non-small cell lung cancer (NSCLC) receiving similar cisplatin pemetrexed-based regimens.

“The SAKK19/09 trial examined a total of 77 patients with EGFR wild type non-squamous NSCLC. Both cohorts received cisplatin pemetrexed in the frontline, while one cohort had the addition of bevacizumab. In an interview with Targeted Oncology, Oliver Gautschi, MD, Assistant Professor, University of Bern, President, SAKK Lung Cancer Group, discusses the lack of differences in overall survival, where the field is going as a whole, and why combination maintenance therapy is not better than a single agent.”

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Sacituzumab Govitecan Shows Promise for Metastatic NSCLC

Excerpt:

“Treatment with sacituzumab govitecan induced objective responses and appeared tolerable in patients with metastatic non–small cell lung cancer who had received first-line platinum-based therapy, according to the results from an expansion cohort of a phase 1/2 study presented at the ASCO Annual Meeting.

” ‘This therapy showed efficacy for squamous and non-squamous patients as well as for patients with prior PD-1/PD-L1 therapy,’ D. Ross Camidge, MD, PhD, professor in the division of medical oncology and Joyce Zeff chair in lung cancer research at University of Colorado Anschutz Medical Campus, said during a presentation.

Sacituzumab govitecan (IMMU-132, Immunomedics) is an antibody drug conjugate comprised of SN-38 — the active metabolite of irinotecan, a topoisomerase inhibitor — conjugated to an anti–Trop-2 humanized monoclonal antibody.”

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CHMP Recommends EU Approval for Roche's Avastin in Combination With Tarceva for Patients With a Specific Type of Advanced Lung Cancer

Excerpt:

“Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Union’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the use of Avastin® (bevacizumab) in combination with Tarceva® (erlotinib) for the first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) activating mutations. NSCLC is the most common type of lung cancer, the leading cause of cancer-related death in Europe and across the world. Approximately 10-15 percent of Europeans with NSCLC will have tumours with EGFR-activating mutations, representing an estimated 33,000 cases in Europe per year or 90 every day.”

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EU Expands Nivolumab Approval for Lung and Kidney Cancer

Excerpt:

“The European Commission has approved new indications for the immunotherapy nivolumab (Opdivo, Bristol-Myers Squibb), expanding its use in the treatment of non-small-cell lung cancer (NSCLC), and adding the indication of renal cell carcinoma (RCC).

“The drug is already approved in Europe for use in previously treated patients with metastatic squamous NSCLC. Now the indication has been expanded to include non-squamous NSCLC, which represents 85% of the cases of lung cancer, and monotherapy in locally advanced or metastatic disease.

“Nivolumab is the only PD-1 inhibitor that has been approved for a broad range of patients with previously treated metastatic NSCLC, regardless of PD-L1 expression, and nivolumab is the only approved PD-1 inhibitor to demonstrate a better overall survival rate than docetaxel in previously treated metastatic NSCLC, the manufacturer pointed out in a press release.”

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