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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FDA Grants Priority Review to Lorlatinib in ALK-Positive NSCLC

Excerpt:

“On February 12, the U.S. Food and Drug Administration (FDA) accepted and granted Priority Review to Pfizer’s new drug application for lorlatinib. The Prescription Drug User Fee Act goal date for a decision by the FDA is in August 2018.

“Lorlatinib is an investigational, anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor for the treatment of patients with ALK-positive metastatic non–small cell lung cancer (NSCLC) previously treated with one or more ALK tyrosine kinase inhibitors. It has been shown to be highly active in preclinical lung cancer models harboring chromosomal rearrangements of both ALK and ROS1. Lorlatinib was specifically designed to inhibit tumor mutations that drive resistance to other ALK inhibitors and to penetrate the blood-brain barrier.”

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Afatinib Approval for Lung Cancer Expanded by FDA

Excerpt:

“The frontline indication for afatinib (Gilotrif) has been expanded by the FDA to include the treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors harbor uncommon EGFR alterations in L861Q, G719X, and/or S768I.

“The FDA initially approved afatinib in 2013 for the treatment of patients with metastatic NSCLC with exon 19 deletions or exon 21 L858R substitutions. In 2016, the FDA expanded the indication to include patients with squamous histology following progression on a platinum-based chemotherapy.”

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Drug Yields High Response Rates for Lung Cancer Patients With Harsh Mutation

Excerpt:

“A targeted therapy resurrected by the Moon Shots Program™ at The University of Texas MD AndersonCancer Center has produced unprecedented response rates among patients with metastatic non-small cell lung cancer that carries a highly treatment-resistant mutation.

“In a phase 2 clinical trial, the drug poziotinib has shrunk tumors by at least 30 percent in eight of 11 (73 percent) non-small cell lung cancer patients whose cancer includes an epidermal growth factor receptor (EGFR) mutation called an exon 20 insertion.  Shrinkage ranged from 30 percent to 50 percent among the eight patients reaching partial response.  One patient has progressed on the clinical trial, which began in March.  All patients experienced some tumor shrinkage.”

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Adding Radiation Treatments to Inoperable Lung Cancer Increases Survival by up to One Year

Excerpt:

“Patients with unresectable, or inoperable, lung cancer are often given a dismal prognosis, with low rates of survival beyond a few years. Researchers exploring combination therapies have recently discovered improved survival rates by up to one year when patients treated with a newly formulated chemotherapy regimen are also given radiation therapy.

“A group of patients with metastatic non-small-cell lung cancer (mNSCLC) who had already been enrolled in a clinical trial were given radiation therapy, in addition to their treatment with a novel chemotherapy formulation, mPEBev, which was designed for its immune-modulating and anti-angiogenic effects. The mPEBev regimen is composed of fractionated cisplatin, oral etoposide, and bevacizumab, a monoclonal antibody that inhibits blood vessel growth in the tumor. Treatments were administered metronomically, spaced out in the safest possible doses to reduce side-effects and toxicity.”

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FDA Approves Tafinlar Plus Mekinist for BRAF V600E–Mutant Non–Small Cell Lung Cancer

Excerpt:

“The FDA approved use of dabrafenib in combination with trametinib for treatment of patients with metastatic non–small cell lung cancer whose tumors harbor BRAF V600E mutations, according to the agents’ manufacturer.

“The combination of dabrafenib (Tafinlar, Novartis) — a BRAF inhibitor — and trametinib (Mekinist, Novartis), a MEK1/2 inhibitor — is the first targeted treatment approved in the United States specifically for patients with BRAF V600E–positive metastatic NSCLC.”

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Durable Responses Seen With Sacituzumab Govitecan in NSCLC

Excerpt:

“The antibody-drug conjugate sacituzumab govitecan (IMMU-132) was well-tolerated and produced a median duration of response of 6.0 months in previously treated patients with metastatic non–small cell lung cancer (NSCLC), according to results from a single-arm, multicenter trial.

“The results, which were published online in the Journal of Clinical Oncology, showed a median progression-free survival of 5.2 months (95% CI, 3.2-7.1) and median overall survival of 9.5 months (95% CI, 5.9-16.7) in the intent-to-treat population. The clinical benefit rate of 43%.”

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Avelumab Shows Promise as Frontline Immunotherapy Alternative in NSCLC

Excerpt:

“Immunotherapy is quickly becoming a mainstay in the frontline setting for the treatment of patients with metastatic non–small cell lung cancer (NSCLC).

“In October 2016, the FDA approved the PD-1 inhibitor pembrolizumab (Keytruda) as a first-line treatment for patients with metastatic NSCLC whose tumors have at least 50% PD-L1 expression and who do not harbor EGFR or ALK mutations.”

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Atezolizumab Improves Survival vs Docetaxel in Previously Treated Non–Small Cell Lung Cancer

Excerpt:

“In the phase III OAK trial reported in The Lancet by Rittmeyer et al, treatment with the anti–programmed cell death ligand 1 (PD-L1) antibody atezolizumab (Tecentriq) improved overall survival vs docetaxel in previously treated non–small cell lung cancer (NSCLC). Results of the trial supported the recent approval of atezolizumab in metastatic NSCLC in patients who have received prior platinum-containing therapy.”

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