Keytruda Alone Bests Chemo in Advanced NSCLC

Excerpt:

“Patients with advanced non-small-cell lung cancer (NSCLC) treated with pembrolizumab (Keytruda) had a greater median survival than patients treated with standard chemotherapy, even if the former had low levels of PD-L1, researchers reported here.

“Depending on the percentage of PD-L1 expression in the tumor, survival was between 4 and 8 months longer for patients treated with immunotherapy alone versus those treated with chemotherapy, according to Gilberto Lopes, MD, MBA, of the Sylvester Comprehensive Cancer Center at the University of Miami, and colleagues.”

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Six Tips to Spot Cancer ‘Fake News’

Excerpt:

Cancer is a popular topic for the media, as people care and worry about it in equal measure.

“News reports help people find out what researchers are working on, and how charitable donations are being spent. They also helps generate interest in the amazing science going on. But perhaps most of all, health stories and clinical trial results have a direct impact on people, raising interest in the latest discoveries further.

“And when it comes to , the emotion that’s tied to the subject means that scientific results must be discussed in a measured and accurate way. And most of the time that’s exactly what happens.”

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High Major Pathologic Response With Neoadjuvant Nivolumab in Resectable NSCLC

Excerpt:

“Immunotherapies targeting PD-1 and PD-L1 have become standards-of-care across all lines of therapy for patients with metastatic non-small cell lung cancer (NSCLC) who do not have targetable driver mutations. Furthermore, the PD-L1 inhibitor durvalumab was recently approved as consolidation therapy after chemoradiation in locally advanced NSCLC.  Based on the improved outcomes seen with these agents in advanced NSCLC, they are now being evaluated in early stage NSCLC where effective therapies are needed, as many patients (particularly those beyond stage IB) relapse after surgery, despite neoadjuvant/adjuvant chemotherapy.”

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Atezolizumab Plus Carboplatin/Nab-Paclitaxel Improves OS in Frontline NSCLC

Excerpt:

“Adding atezolizumab (Tecentriq) to nab-paclitaxel (Abraxane) and carboplatin in the frontline setting significantly improved overall survival (OS) in patients with advanced non–small cell lung cancer (NSCLC), according to findings from the phase III IMpower130 study.

“Atezolizumab also improved progression-free survival (PFS), the coprimary endpoint of the IMpower130 study, according to Genentech (Roche), the manufacturer of the PD-L1 inhibitor. The company plans to share the study data at an upcoming oncology meeting.”

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Alectinib Outpaces Crizotinib In Treatment of ALK+ NSCLC Patients in Phase 3 ALEX Trial

Excerpt:

“At the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting, researchers announced updated results from the phase 3 ALEX trial which compared alectinib with crizotinib for the treatment of those with ALK-positive non-small cell lung cancer (NSCLC).

“The results reveal that 152 patients treated with alectinib showed a median progression-free survival (PFS) of 34.8 months compared with just 10.9 months in the 151 patients who were treated with crizotinib.”

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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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Practice-Changing Developments in Treatment of Metastatic NSCLC


Immune checkpoint inhibitor drugs that target the proteins PD-1 and PD-L1 are by now well established in the treatment of non-small cell lung cancer (NSCLC). In 2015, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo), an anti-PD-1 drug, for treatment of patients with metastatic NSCLC who progressed or relapsed after platinum-based chemotherapy. Atezolizumab (Tecentriq), an anti-PD-L1 drug, was approved in 2016 for treatment of NSCLC patients in the same situation. In October 2016, the FDA approved Pembrolizumab (Keytruda), a competing anti-PD-1 antibody, as first-line treatment in metastatic NSCLC patients whose tumors have high expression levels of the PD-L1 protein.

With these approvals, the stage was set to move these drugs into combination treatments that may increase their efficacy. Not surprisingly, combinations with chemotherapy have now been explored, among other possibilities. Continue reading…


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 Accepts sBLA, Grants Priority Review to Atezolizumab for Initial Treatment of Metastatic Nonsquamous NSCLC

Excerpt:

“The U.S. Food and Drug Administration (FDA) recently accepted a supplemental biologics license application (sBLA) and granted Priority Review for atezolizumab (Tecentriq) in combination with bevacizumab (Avastin), paclitaxel, and carboplatin for the first-line treatment of metastatic nonsquamous non–small cell lung cancer (NSCLC). The FDA is expected to make a decision on approval by September 5, 2018.

” ‘Our phase III results showed atezolizumab in combination with bevacizumab, paclitaxel, and carboplatin has the potential to provide a significant survival benefit in the initial treatment of metastatic nonsquamous non–small cell lung cancer,’ said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development at Genentech.”

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