Roche’s Tecentriq, Trailing Rival Drugs, Lifts Lung Cancer Survival

Excerpt:

“A drug cocktail with Roche’s Tecentriq added two months to small-cell lung cancer patients’ lives, according to a study, aiding the Swiss group’s bid to win approval in a niche disease area before rivals that now dominate the immunotherapy market.

“Patients with untreated extensive-stage small-cell lung cancer (SCLC), where cancer has spread, lived a median 12.3 months after getting Tecentriq plus chemotherapy.”

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First-Line Atezolizumab Plus Chemotherapy Improves PFS for Lung Cancer

Excerpt:

“The addition of frontline atezolizumab to carboplatin or cisplatin plus pemetrexed improved PFS among patients with non-small cell lung cancer, according to interim results from a global phase 3 randomized trial presented at International Association for the Study of Lung Cancer’s World Conference on Lung Cancer.

“IMpower132 is an open-label study of atezolizumab (Tecentriq, Genentech) — a PD-L1 inhibitor — among 578 chemotherapy-naive patients with stage IV nonsquamous NSCLC. Exclusion criteria included EGFR or ALK mutations, untreated central nervous system metastases, autoimmune disease and prior exposure to immunotherapy.”

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Novel Agents are Changing the Face of Metastatic TNBC

Excerpt:

“Only 1 treatment option is currently available for treating patients with metastatic germline BRCA-mutated triple-negative breast cancer (TNBC), but research into novel therapies, including PI3K/conjugates (ADCs) could soon result in a host of new therapies for this hard-to-treat disease.

” ‘Right now, for TNBC, chemotherapy is our only option,’ said Joyce A. O’Shaughnessy, MD, co-chair of Breast Cancer Research and the chair of Breast Cancer Prevention Research at Baylor-Sammons Cancer Center and for The US Oncology Network. ‘That’s about to change very soon with the likely availability of atezolizumab [Tecentriq].’ ”

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Study Describes Design, Validation of Foundation Medicine’s Blood-Based TMB Test

Excerpt:

“Researchers from Genentech, Foundation Medicine, UC Davis, and other medical centers, have published a report on the development and early validation of Foundation’s planned blood-based tumor mutational burden test.

“Appearing today in Nature Medicine, the study describes the development of the test and its characteristics, and its retrospective validation in two cohorts. Investigators demonstrated, by applying the assay to samples from two clinical trials, that blood-based TMB (bTMB) could reproducibly identify lung cancer patients who respond to immunotherapy treatment with Roche/Genentech’s atezolizumab (Tecentriq).”

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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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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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