FDA Grants Priority Review to Keytruda Plus Chemotherapy for Lung Cancer Subtype

Excerpt:

“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.”

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FDA Expands Approval of Pembrolizumab for First-Line Treatment of NSCLC

Excerpt:

“The U.S. Food and Drug Administration (FDA) recently granted accelerated approval to the immune checkpoint inhibitor pembrolizumab (Keytruda) for use in combination with chemotherapy as a first-line treatment for patients with metastatic non–small cell lung cancer (NSCLC).

“This new approval of pembrolizumab was based on the results of the phase II KEYNOTE-021 clinical trial of 123 patients with advanced or metastatic nonsquamous NSCLC without mutations in the EGFR gene or alterations in the ALK gene, for which there are existing targeted therapies. Patients in the trial had not been treated previously and were randomly assigned to receive either pembrolizumab plus chemotherapy or chemotherapy alone.”

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Selective AXL Inhibitor Bemcentinib Meets Pre-specified Efficacy Endpoint in Stage 1 of NSCLC Phase II Combination Trial With KEYTRUDA

Excerpt:

“BerGenBio ASA (OSE:BGBIO) announces today that on a top-line, preliminary basis, the first efficacy endpoint has been met in its Phase II clinical trial (BGBC008) evaluating bemcentinib, a first-in-class oral selective AXL inhibitor, in combination with the Merck & Co., Inc., Kenilworth, N.J., USA[1] anti-PD-1 therapy KEYTRUDA® (pembrolizumab) as a potential new treatment regimen for advanced non-small cell lung cancer (NSCLC). The primary efficacy endpoint requires at least four patients (out of the first 22 treated patients) to achieve clinical responses when treated with the novel drug combination, defined as either complete or partial response, as measured by Response Evaluation Criteria in Solid Tumors (RECIST).”

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Immunotherapy Outcomes May Be Better in Older Patients With Melanoma

Excerpt:

“Older patients with melanoma may respond better to anti-PD-1 immunotherapy treatment than their younger counterparts, according to a recent study published in Clinical Cancer Research, a journal from the American Association for Cancer Research.

“Researchers collected melanoma tissue samples from 538 patients from the United States, Australia and Germany. The samples were then divided into two categories: those belonging to people over the age of 62 and those belonging to people younger than 62. All of the patients were treated with the immunotherapy agent, Keytruda (pembrolizumab), which targets and blocks PD-1, making the immune system more likely to identify and attack cancer cells.”

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Niraparib/Pembrolizumab Combo Active in Relapsed, Progressive TNBC

Excerpt:

“Half of patients with metastatic triple-negative breast cancer (TNBC) achieved disease control when treated with the combination of a poly (ADP-ribose) polymerase (PARP) inhibitor and an anti–PD-1 agent, a preliminary prospective study showed.

“Overall, 13 of 46 evaluable patients had objective responses to treatment with niraparib (Zejula) and pembrolizumab (Keytruda). An additional 10 patients had stable disease. Clinical activity was observed in patients beyond those with germline BRCA mutations.”

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Immunotherapy Could Stop Prostate Cancer Spreading, Trial Shows

Excerpt:

“Men with otherwise untreatable prostate cancer could halt its spread and survive longer by undergoing immunotherapy treatment, a trial has shown.

“More than a third of men with an advanced form of the cancer were still alive and one-in-10 had not had further growth after a year on the drug pembrolizumab, the study found.

“It is the first time immunotherapy has been shown to benefit some men with prostate cancer, the researchers said.”

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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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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…


Frontline Pembrolizumab Combo Submitted for FDA Approval in Squamous NSCLC

Excerpt:

“The FDA has received a supplemental biologics license application (sBLA) seeking approval for pembrolizumab (Keytruda) in combination with standard chemotherapy as a treatment for patients with metastatic squamous non–small cell lung cancer (sNSCLC).

“The application is based on findings from the phase III KEYNOTE-407 trial (NCT02775435),  which evenly randomized 560 treatment-naive patients with metastatic squamous NSCLC to pembrolizumab combined with carboplatin/paclitaxel or nab-paclitaxel (Abraxane), carboplatin/paclitaxel alone, or nab-paclitaxel alone. The coprimary endpoints were overall survival (OS) and progression-free survival (PFS). Secondary endpoints included objective response rate (ORR) and duration of response.”

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