FDA Approves Lorlatinib for Second- or Third-Line Treatment of ALK-Positive Metastatic NSCLC

Excerpt:

“On November 2, 2018, the Food and Drug Administration granted accelerated approval to lorlatinib (LORBRENA, Pfizer, Inc.) for patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease.

“Approval was based on a subgroup of 215 patients with ALK-positive metastatic NSCLC, previously treated with one or more ALK kinase inhibitors, enrolled in a non‑randomized, dose-ranging and activity-estimating, multi‑cohort, multicenter study (Study B7461001; NCT01970865). The major efficacy measures were overall response rate (ORR) and intracranial ORR, according to RECIST 1.1, as assessed by an independent central review committee.”

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Pembrolizumab Regimen Receives FDA Approval for Frontline Treatment of Squamous NSCLC

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.”

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Aggressive RT, Surgery Doubles OS in NSCLC With Limited Mets

Excerpt:

“Aggressive local consolidation in stage IV non-small lung cancer (NSCLC) drastically improved overall survival over standard care in patients with up to three metastatic lesions, a small randomized study found.

“Among 49 patients whose disease had not progressed after initial systemic therapy, overall survival was 41.2 months in those treated with radiotherapy or surgery compared with 17.0 months in those on standard maintenance therapy (P=0.017), reported Daniel Gomez, MD, of MD Anderson Cancer Center in Houston, at a press briefing here at the American Society for Radiation Oncology (ASTRO) meeting.”

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Liquid Biopsy IDs More NSCLC Mutations, Yields Patient Therapy Response in Study of Guardant Test

Excerpt:

“New data this week has added evidence for the value of blood-based cancer testing in non-small cell lung cancer, demonstrating in a cohort of about 300 that comprehensive liquid biopsy — in this case Guardant Health’s Guardant360 test — can help identify targeted mutations in more patients than tissue sequencing.

“The study also found that patients treated on the basis of blood-based test results respond to treatment similarly to those treated based on tissue test results.”

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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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Pembrolizumab Plus Chemotherapy Prolongs OS, PFS for Metastatic Lung Cancer

Excerpt:

“The addition of pembrolizumab to chemotherapy extended OS and PFS compared with chemotherapy alone among patients with metastatic, squamous, non-small-cell lung cancer, according to results of the randomized phase 3 KEYNOTE-407 trial presented at International Association for the Study of Lung Cancer’s World Conference on Lung Cancer.

“The double-blind study included 559 treatment-naive patients with metastatic, squamous NSCLC. Patients who had symptomatic central nervous system metastases, a history of noninfectious pneumonitis that required the use of glucocorticoids, active autoimmune disease or who were receiving systemic immunosuppressive treatment were excluded.”

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Repotrectinib Shows Promising Activity in ROS1+ NSCLC

Excerpt:

“Repotrectinib (TPX-0005) demonstrated a clinically meaningful and durable benefit across multiple doses in patients with ROS1 fusion–positive non–small cell lung cancer (NSCLC).

“Overall response rates (ORRs) were 80% for tyrosine kinase inhibitor (TKI)-naïve patients (95% CI, 44-97) and 18% for TKI-refractory patients (95% CI, 4-44), including 33% for those who received a dose of 160 mg once daily, according to findings from the ongoing phase I/II TRIDENT-1 study. Interim analysis results were presented at the 19th World Conference on Lung Cancer (WCLC).”

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LOXO-292 Safe, Effective for RET-Altered Non-Small Cell Lung Cancer

Excerpt:

“LOXO-292 appeared well tolerated and demonstrated antitumor activity among patients with heavily pretreated RET fusion-positive non-small cell lung cancer, according to updated interim results of a global, phase 1/phase 2 trial presented at International Association for the Study of Lung Cancer’s World Conference on Lung Cancer.

“Researchers reported initial clinical data from the LIBRETTO-001 dose escalation/expansion study of LOXO-292 (Loxo Oncology) — an oral and selective agent in clinical development for cancers that harbor abnormalities in the rearranged during transfection (RET) kinase — at ASCO Annual Meeting in June.”

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Novel Agent Active in ROS1-Mutant NSCLC

Excerpt:

“Three-fourths of patients with ROS1-positive non-small cell lung cancer (NSCLC) had objective responses lasting an average of 2 years with an investigational multikinase inhibitor, a preliminary trial showed.

“Overall, 41 of 53 patients responded to treatment with entrectinib, including 17 of 33 patients with central nervous system (CNS) metastases at baseline. Responses had a median duration of 24.6 months among patients without CNS metastases and 13.6 months among those with CNS metastases.”

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