Tecentriq Add-On Improved Outcomes in Untreated Advanced Lung Cancer Patients

Excerpt:

“Adding Tecentriq (atezolizumab) to a treatment of Avastin (bevacizumab) and chemotherapy significantly prolonged the time to disease progression or death in people with previously untreated advanced non-squamous non-small cell lung cancer (NSCLC).

“The results stem from a Phase 3 trial of 1,202 people, with data also indicating better overall survival in patients treated with Tecentriq. Improved progression-free and overall survival were the two main trial outcome measures.”

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Ramalingam Shares Notable Updates in NCCN Guidelines for EGFR+ NSCLC

Excerpt:

“Among the notable updates in the National Comprehensive Cancer Network’s (NCCN) recently released  treatment guidelines for non–small cell cancer (NSCLC) is the category 2A recommendation to give osimertinib (Tagrisso), a third-generation irreversible EGFR inhibitor designed to inhibit both EGFR-sensitizing and EGFR T790M-resistance mutations, in the first-line setting for patients whose disease is EGFR mutant, explains Suresh A. Ramalingam, MD.

“Osimertinib was also given a category 1 recommendation as a subsequent therapy after patients progressed on treatment with standard EGFR tyrosine kinase inhibitors (TKIs) erlotinib (Tarceva), gefitinib (Iressa), and afatinib (Gilotrif). The FDA granted a breakthrough therapy designation to a supplemental biologics license application for osimertinib as a frontline treatment for patients with metastatic EGFR-mutation–positive NSCLC in October 2017. The application was based on findings from the double-blind, phase III FLAURA trial, in which frontline osimertinib was associated with a 54% reduction in the risk of progression or death compared with standard therapy.”

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Prior Treatment With PD-1/PD-L1 Inhibitors Improves Responses to Salvage Chemotherapy in NSCLC

Excerpt:

“Immune checkpoint inhibitors have significantly reshaped the treatment landscape of advanced non-small cell lung cancer (NSCLC) in the second-line and, more recently, in the first-line setting. However, only a subset of patients achieves a durable response on immunotherapy, and it is not clear whether prior immunotherapy treatment impacts response to salvage chemotherapy.

A recent retrospective study evaluated responses to salvage chemotherapy in 73 patients with advanced NSCLC who had progressed on prior PD-1/PD-L1 inhibitors. Ten of the 73 patients had received immunotherapy as first-line treatment, while the remaining 63 patients had received immunotherapy as second-line treatment following first-line chemotherapy. Response to salvage chemotherapy was compared to response to the last chemotherapy administered before immunotherapy (LCBI).”

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IMpower150 Trial Delays Progression in Advanced NSCLC With Atezolizumab/Bevacizumab Combo

Excerpt:

“In topline results announced from the phase III IMpower150 trial, atezolizumab (Tecentriq) in combination with bevacizumab (Avastin) and chemotherapy delayed progression or death when compared with bevacizumab and chemotherapy alone for patients with advanced nonsquamous non–small cell lung cancer (NSCLC).

“The co-primary endpoints for the IMpower150 study were progression-free survival (PFS) and overall survival (OS). Although exact numbers have not yet been released, Roche, the manufacturer of the anti–PD-L1 and anti–VEGF agents, called the reduction in progression or death with the addition of atezolizumab a ‘clinically meaningful reduction’ in a press release. At the interim analysis, data for OS were not yet mature, with the company labeling the findings as ‘encouraging.’ ”

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Update Sustains Osimertinib Activity Against CNS Mets in NSCLC

Excerpt:

“New results again demonstrated the benefit of frontline osimertinib (Tagrisso) in patients with EGFR-positive advanced non–small cell lung cancer (NSCLC) and CNS metastases at baseline, according to data presented at the 2017 ESMO Asia Congress.

“The subgroup analysis from the phase III FLAURA trial included 128 patients with at least 1 measurable and/or nonmeasurable CNS lesion at baseline. Among 61 patients who received osimertinib, the CNS objective response rate (ORR) was 66%, compared to 43% (odds ratio, 2.5; 95% CI 1.2-5.2; P = .011) in 67 patients who received standard EGFR TKI therapy with erlotinib (Tarceva) or gefitinib (Iressa).”

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Atezolizumab plus Bevacizumab and Chemotherapy Extends PFS in Non-Small Cell Lung Cancer

Excerpt:

“The addition of atezolizumab to first-line treatment with bevacizumab and chemotherapy significantly prolonged PFS among individuals with advanced nonsquamous non-small cell lung cancer, according to the agent’s manufacturer.

Atezolizumab (Tecentriq, Genentech) is a monoclonal antibody designed to bind with PD-L1.

“The randomized, multicenter, open-label phase 3 IMpower150 study assessed the efficacy and safety of atezolizumab in combination of chemotherapy with or without bevacizumab (Avastin, Genentech) for patients with stage IV nonsquamous NSCLC who had not undergone chemotherapy for their advanced disease.”

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Bevacizumab Does Not Improve Outcomes With Chemotherapy in Early NSCLC

Excerpt:

“The addition of bevacizumab to adjuvant chemotherapy failed to improve survival outcomes in patients with surgically resected early-stage non–small-cell lung cancer (NSCLC), according to a new randomized trial. The agent “does not have a role” in this setting, the investigators concluded.

” ‘In the setting of advanced-stage NSCLC, the first agent to improve survival when added to a platinum doublet was bevacizumab,’ wrote authors led by Heather A. Wakelee, MD, of the Stanford Cancer Institute at Stanford University in California. The researchers tested whether the VEGF-targeted agent would be similarly effective in the early-stage NSCLC adjuvant setting, where patients remain at high risk of relapse despite chemotherapy.”

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NKTR-214/Nivolumab Combination Shows Promise in Early Study

Excerpt:

“The combination of the CD122-biased cytokine NKTR-214 and the PD-1 inhibitor nivolumab (Opdivo) demonstrated target lesion reductions of 72% for patients with advanced cancers, according to findings from the phase Ib PIVOT-02 trial presented at the 2017 SITC Annual Meeting.

“The dose escalation trial enrolled patients in the first- or second-line setting with advanced non–small cell lung cancer (NSCLC), renal cell carcinoma (RCC), and melanoma. The objective response rates (ORR) by RECIST criteria ranged from 46% to 75% across tumor types. Additionally, the combination was tolerable, with no discontinuations attributed to adverse events (AEs).”

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FDA Approves Roche’s Alecensa (Alectinib) as First-Line Treatment for People With Specific Type of Lung Cancer

Excerpt:

“Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Alecensa® (alectinib) for the treatment of people with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. The approval is based on results from the phase III ALEX study, which showed Alecensa significantly reduced the risk of disease worsening or death (progression-free survival, PFS) by 47% (HR=0.53, 95% CI: 0.38, 0.73, p<0.0001) compared to crizotinib as assessed by independent review committee (IRC). Median PFS was 25.7 months (95% CI: 19.9, not estimable) for people who received Alecensa compared with 10.4 months (95% CI: 7.7, 14.6) for people who received crizotinib. The safety profile of Alecensa was consistent with that observed in previous studies. The study also showed that Alecensa significantly reduced the risk of the cancer spreading to or growing in the brain or central nervous system (CNS) compared to crizotinib by 84% (HR=0.16, 95% CI: 0.10, 0.28, p<0.0001). This was based on a time to CNS progression analysis in which there was a lower risk of progression in the CNS as the first site of disease progression for people who received Alecensa (12%) compared to people who received crizotinib (45%).”

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