FDA Approves Vizimpro for EGFR-Mutated Non-Small Cell Lung Cancer

Excerpt:

“The FDA approved dacomitinib for the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have EGFR exon 19 deletion or exon 21 L858R substitution mutations.

“Dacomitinib (Vizimpro, Pfizer) is a once-daily oral pan-human EGFR tyrosine kinase inhibitor.”

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Studies Confirm Osimertinib Activity in Brain Mets

Excerpt:

“The resistance mutation-targeting EGFR inhibitor osimertinib (Tagrisso) demonstrated superior activity against central nervous system (CNS) metastases as compared with chemotherapy or nonselective EGFR inhibitors, two randomized trials of patients with lung cancer showed.

“In a comparison involving patients with untreated EGFR-mutated advanced non-small cell lung cancer (NSCLC), the median CNS progression-free survival (PFS) was not reached in patients who received osimertinib or a first-generation EGFR inhibitor. However, the available data favored the osimertinib arm (95% CI 16.5 months to not reached versus 13.9 months to not reached, HR 0.48, 95% CI 0.26-0.86, P=0.014). Osimertinib also led to a higher response rate.”

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CNS Activity of EGFR Tyrosine Kinase Inhibitor in T790M-Positive Advanced NSCLC

Excerpt:

“In a planned subgroup analysis of the phase III AURA3 trial reported in the Journal of Clinical Oncology, Wu et al found that the third-generation EGFR tyrosine kinase inhibitor osimertinib (Tagrisso) produced higher central nervous system (CNS) response rates vs platinum plus pemetrexed (Alimta) in patients with advanced EGFR T790M-positive non–small cell lung cancer (NSCLC).

“In AURA3, 419 patients with disease progression on prior EGFR tyrosine kinase inhibitor treatment were randomized 2:1 to receive osimertinib at 80 mg once daily or platinum plus pemetrexed. The current subgroup analysis was conducted in patients with measurable or nonmeasurable CNS lesions on baseline brain scan by blinded independent central neuroradiologic review.”

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Adding Bevacizumab to Erlotinib Prolongs PFS in EGFR-Mutated NSCLC

Excerpt:

“The combination of bevacizumab (Avastin) and erlotinib (Tarceva) is superior to erlotinib alone as upfront treatment for non–small cell lung cancer (NSCLC) harboring EGFR mutations. A preplanned interim analysis of the phase III study known as NEJ026 showed a median progression-free survival (PFS) by independent review (the primary endpoint) of 16.9 months with the bevacizumab/erlotinib combination compared with 13.3 months with erlotinib by itself, said Naoki Furuya, MD, PhD, at the 2018 ASCO Annual Meeting.”

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AstraZeneca Wins U.S. Approval for 1st-Line Use of Lung Cancer Drug

Excerpt:

“U.S. regulators have expanded use of AstraZeneca’s lung cancer drug Tagrisso to include initial treatment of patients with a specific genetic mutation, the company said on Wednesday.

“The latest Food and Drug Administration approval includes patients with metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test.

“Tagrisso, also known as osimertinib, was already approved for use in patients whose lung cancer worsened after treatment with other EGFR therapies and who have developed a secondary mutation.”

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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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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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Targetable Mutations in NSCLC: More Testing Needed!


Diagnosis of adenocarcinoma of the lung, a major subtype of non-small lung cancer (NSCLC), nowadays triggers mandatory testing of tumor tissue for alterations in four genes: EGFR, ALK, ROS1, and more recently, BRAF. If present, these alterations predict sensitivity to specific targeted drugs approved by the U.S. Food and Drug Administration (FDA) that work better and often longer than standard chemotherapy, and are better tolerated.

However, there are many more targetable/actionable genomic alterations (also known as “drivers”) in NSCLC. This blog post will briefly discuss most of them, with the goal of promoting molecular testing for more than the four “usual suspects” mentioned above. Some patients with these alterations may benefit from FDA-approved drugs or from enrollment in clinical trials that are testing additional drugs and drug combinations. Continue reading…


FDA Grants Frontline Osimertinib Priority Review for NSCLC

Excerpt:

“The FDA has granted a priority review to a supplemental new drug application (sNDA) for the use of osimertinib (Tagrisso) as a first-line treatment for patients with non–small cell lung cancer (NSCLC) whose tumors harbor EGFR mutations (exon 19 deletions or exon 21 [L858R] substitution mutations).

“The sNDA is based on the phase III FLAURA study, in which frontline osimertinib reduced the risk of progression or death by 54% versus standard TKI therapy—erlotinib (Tarceva) or gefitinib (Iressa). In the double-blind study, the median progression-free survival (PFS) was 10.2 months (95% CI, 9.6-11.1) for standard therapy and 18.9 months (95% CI, 12.5-21.4) with osimertinib (HR, 0.46; 95% CI, 0.37-0.57; P <.0001).”

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