Keytruda (Pembrolizumab) Monotherapy Met Primary Endpoint in Phase 3 KEYNOTE-042 Study, Significantly Improving OS as First-Line Therapy in Locally Advanced or Metastatic NSCLC Patients Expressing PD-L1 in at Least 1 Percent of Tumor Cells

Excerpt:

“Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the pivotal Phase 3 KEYNOTE-042 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC, including nonsquamous or squamous histologies) met its primary endpoint of overall survival (OS). An interim analysis conducted by the independent Data Monitoring Committee (DMC) demonstrated that treatment with KEYTRUDA resulted in significantly longer OS than platinum-based chemotherapy (carboplatin plus paclitaxel or carboplatin plus pemetrexed) in patients with a PD-L1 tumor proportion score (TPS) of ≥1 percent. As part of a pre-specified analysis plan, OS was sequentially tested and was significantly improved in patients with a TPS of ≥50 percent, with a TPS of ≥20 percent and then in the entire study population with a TPS of ≥1 percent. The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported monotherapy studies involving patients with advanced NSCLC.”

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New Immunotherapy for Lung Cancer Shows Promise of Success

Excerpt:

“In a groundbreaking development, results from a recent clinical trial to treat lung cancer show that a novel immunotherapy combination is surprisingly effective at controlling the disease’s progression. The study, published April 4 in the journal The Lancet Oncology, focused on non-small cell lung cancer, which is the most common form of lung cancer.”

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Phase III IMpower150 Study Showed Roche’s TECENTRIQ (Atezolizumab) and Avastin (Bevacizumab) Plus Carboplatin and Paclitaxel Helped People with Advanced Lung Cancer Live Longer Compared to Avastin Plus Carboplatin and Paclitaxel

Excerpt:

“Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Phase III IMpower150 study met its co-primary endpoint of overall survival (OS) at this interim analysis and showed that initial (first-line) treatment with the combination of TECENTRIQ® (atezolizumab) and Avastin® (bevacizumab) plus carboplatin and paclitaxel (chemotherapy) helped people with advanced non-squamous non-small cell lung cancer (NSCLC) live significantly longer compared with Avastin plus carboplatin and paclitaxel. A survival benefit was observed across key subgroups, including those with varying levels of PD-L1 expression. Safety for the TECENTRIQ and Avastin plus carboplatin and paclitaxel combination appeared consistent with the known safety profile of the individual medicines, and no new safety signals were identified with the combinations. These data will be presented at an upcoming oncology congress.”

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Tecentriq Combo Success Boosts Roche in Lung Cancer

Excerpt:

“A combination of Roche AG’s immunotherapy Tecentriq with two older cancer drugs bested chemotherapy in extending progression-free survival (PFS) among previously untreated patients with squamous non-small cell lung cancer (NSCLC), the Swiss pharma announced March 20.

“Results from the Phase 3 study, known as IMpower 131, could position Tecentriq as the first checkpoint inhibitor to market for first-line treatment of squamous NSCLC, a subset that accounts for 25% to 30%of all NSCLC cases.

“Roche only disclosed topline results for the combination regimen’s effect on PFS. At this point, no benefit in overall survival (OS) between the treatment and control groups was reported, but the study will continue to allow for further observation.”

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No Benefit of PD-1/PD-L1 Inhibitors in Metastatic EGFR Mutated Non-Small Cell Lung Cancer

Excerpt:

“Immune checkpoint inhibitors have revolutionized the treatment of metastatic non-small cell lung cancer (NSCLC). In patients progressing on first-line therapy, immunotherapy with the PD-1/PD-L1 inhibitors pembrolizumab, nivolumab, and atezolizumab has become standard second-line therapy. While these agents are associated with durable responses and long-term improvements in overall survival (OS), only a small proportion of patients respond to treatment. Relatively little is known about the factors that predispose patients to response on checkpoint inhibitors, and there is an unmet need for improved patient selection criteria.”

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Salvage Immunotherapy Viable for Non-Small Cell Lung Cancer

Excerpt:

“Immunotherapy remains a viable option for pretreated patients with non-small cell lung cancer, but the data are rapidly evolving, according to a presenter at HemOnc Today New York.

” ‘We have come a long way with the development of checkpoint inhibitors, and we have to remember that they became famous and exerted their effect in the chemotherapy-refractory setting first,’ Benjamin Levy, MD, assistant professor of oncology at Johns Hopkins University and clinical director of Sidney Kimmel Cancer Center at Sibley Memorial Hospital in Washington, said during his presentation.”

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Interest Builds in Targeting MET Mutations in Non-Small Cell Lung Cancer

Excerpt:

“Although checkpoint blockade immunotherapies have advanced rapidly in the treatment paradigm for patients with non–small cell lung cancer (NSCLC), interest in developing targeted therapies for this malignancy has remained high. Building on the success of molecularly targeted drugs aimed at relatively small subsets of patients, researchers are increasingly aiming at the MET oncogene.

“During the past several years, interest in MET activity has grown as investigators have considered it both as a biomarker and target for treatment, particularly since the focus on MET exon 14 skipping mutations has led to the development of several second-generation MET inhibitors, according to Balazs Halmos, MD, MS.”

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Avelumab Does Not Improve OS Over Docetaxel in NSCLC, Phase III Trial Shows

Excerpt:

“The primary endpoint of improving overall survival (OS) was not met in the phase III JAVELIN Lung 200 Trial of avelumab (Bavencio) in patients with non–small cell lung cancer (NSCLC), according to Merck KGaA and Pfizer, the co-developers of avelumab.

“According to results of the study, the PD-L1 inhibitor did not improve OS for patients with PD-L1-positive (≥1%) unresectable, recurrent or metastatic NSCLC compared with docetaxel in patients who had progressed on platinum-containing doublet chemotherapy (hazard ratio [HR], 0.90; 96% CI, 0.72-1.12; one-sided P = .1627).”

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Ramalingam Highlights Immunotherapy Advances in NSCLC

Excerpt:

“Recently reported updates from the KEYNOTE-189 and IMpower150 trials demonstrated the powerful impact of adding immunotherapy to treatment regimens for patients with non–small cell lung cancer (NSCLC).

“In the phase III KEYNOTE-189 study, the combination of pembrolizumab (Keytruda) with chemotherapy in the frontline setting improved survival in patients with nonsquamous NSCLC. In this trial, which is the confirmatory trial for the FDA approval of pembrolizumab plus carboplatin/pemetrexed, patients received frontline pembrolizumab or placebo combined with pemetrexed and either cisplatin or carboplatin. The study met the primary endpoints of improved overall survival (OS) and progression-free survival (PFS), though full data have yet to be presented.”

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