pembrolizumab

  •   Emma Shtivelman, PhD

    Excerpt:

    “On April 11, 2019, the Food and Drug Administration approved pembrolizumab (KEYTRUDA, Merck Inc.) for the first-line treatment of patients with stage III non-small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation or metastatic NSCLC. Patients’ tumors must have no EGFR or ALK genomic aberrations and express PD-L1 (Tumor Proportion Score [TPS] ≥1%) determined by an FDA-approved test.

    “Pembrolizumab was previously approved as a single agent for the first-line treatment of patients with metastatic NSCLC whose tumors express PD-L1 TPS ≥50%.”

    Go to full article published by the U.S. Food and Drug Administration on April 11, 2019.

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  •   Emma Shtivelman, PhD

    Excerpt:

    “Pembrolizumab demonstrated antitumor activity and induced durable responses in patients with advanced small cell lung cancer who had received two or more previous lines of therapy, according to pooled data from two KEYNOTE trials presented at American Association for Cancer Research Annual Meeting.”

    Go to full article published by Healio on April 3, 2019

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  •   Emma Shtivelman, PhD

    Excerpt:

    “A single dose of a programmed cell death protein 1 (PD-1) inhibitor before resection for melanoma may predict clinical outcomes for patients. Researchers from the Abramson Cancer Center at the University of Pennsylvania—who documented this finding in the largest cohort of patients to be treated with anti–PD-1 drugs before surgery—also showed that immune responses brought on by this therapy can peak as early as 7 days after treatment—much earlier than previous studies have shown. These findings were published by Huang et al in Nature Medicine.”

    Go to full article published by The ASCO Post on March 7, 2019.

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  •   Emma Shtivelman, PhD

    Excerpt:

    “Based on findings from the phase III KEYNOTE-407 trial, pembrolizumab (Keytruda) has been approved by the FDA for use in combination with carboplatin and either paclitaxel or nab-paclitaxel (Abraxane) for the frontline treatment of patients with metastatic squamous non–small cell lung cancer (NSCLC).

    “Results from the trial showed combining pembrolizumab with chemotherapy reduced the risk of death by 36% compared with chemotherapy alone in patients with metastatic squamous NSCLC. The median overall survival (OS) was 15.9 months (95% CI, 13.2 – not evaluable) with pembrolizumab versus 11.3 months (95% CI, 9.5-14.8) with chemotherapy alone (HR, 0.64; 95% CI, 0.49-0.85; P = .0017). The OS benefit was observed regardless of PD-L1 expression level, choice of taxane, age, sex, and ECOG performance status.”

    Go to full article published by Targeted Oncology on Oct 30, 2018.

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  •   Emma Shtivelman, PhD

    Excerpt from Cancer Network:

    “Researchers found that in patients with non–small-cell lung cancer (NSCLC) and a Tumor Proportion Score (TPS) ≥ 50, pembrolizumab plus chemotherapy failed to improve overall survival (OS) or progression-free survival (PFS) compared with pembrolizumab alone.

    “Results from the study were presented in a poster presentation at the International Association for the Study of Lung Cancer (IASLC) 19th World Conference on Lung Cancer, held September 23–26 in Toronto.”

    Go to full article published by Cancer Network on Sep 24, 2018.

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  •   Emma Shtivelman, PhD

    Excerpt from Cancer Network:

    “A phase I trial found promising activity and good tolerability with the combination of pembrolizumab and a stimulant of Toll-like receptor 9 (TLR9) known as SD-101 in patients with unresectable or metastatic melanoma, particularly in those who had not received prior anti–programmed death 1 (PD-1)/programmed death ligand 1 (PD-L1) therapy.

    “PD-1/PD-L1 inhibition has improved outcomes in metastatic melanoma, and studies have indicated that combination therapy can increase immune responses further. “Despite the improvement in response rates with combination immunotherapy, a large unmet need remains,” wrote study authors led by Antoni Ribas, MD, PhD, of the University of California, Los Angeles, Jonsson Comprehensive Cancer Center.”

    Go to full article published by Cancer Network on Sep 5, 2018.

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  •   Emma Shtivelman, PhD

    Excerpt from The ASCO Post:

    “Today, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) in combination with pemetrexed (Alimta) and platinum as first-line treatment of patients with metastatic, nonsquamous non–small cell lung cancer with no EGFR or ALK genomic tumor aberrations.

    “Pembrolizumab was previously granted accelerated approval for this indication in May 2017 based on improvements in overall response rate and progression-free survival for patients randomized to pembrolizumab administered with pemetrexed and carboplatin as compared with pemetrexed and carboplatin alone in the KEYNOTE-021 study.”

    Go to full article published by The ASCO Post on Aug 20, 2018.

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  •   Emma Shtivelman, PhD

    Excerpt from Healio:

    “The FDA granted priority review designation to a supplemental biologics license application that seeks approval of pembrolizumab for use in combination with chemotherapy as first-line treatment of metastatic squamous non-small cell lung cancer regardless of PD-L1 expression.

    “The agency set a target action date of Oct. 30.”

    Go to full article published by Healio on July 2, 2018.

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