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FDA expands approval of Lorbrena for ALK positive metastatic lung cancer


21/4/2021 | 3 minutes to read

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FDA expands approval of Lorbrena for ALK-positive metastatic lung cancer

FDA expanded the approval of lorlatinib to include the first-line treatment of adults with anaplastic lymphoma kinase-positive metastatic non-small cell lung cancer. The FDA also approved the Ventana ALK (D5F3) CDx Assay as a companion diagnostic to detect ALK for treatment with lorlatinib. The expanded approval of lorlatinib, a third-generation ALK inhibitor, is based on results of the randomized Phase 3 CROWN trial, which included 296 patients with previously untreated advanced ALK-positive NSCLC.

As Healio previously reported, results of the study, published in The New England Journal of Medicine, showed lorlatinib conferred a 72% reduction in the risk for progression or death compared with crizotinib (mPFS, not estimable vs. 9.3 months; HR = 0.28; 95% CI, 0.19-0.41).

Cstone scores approval for Blueprint Medicines’ Gavreto in China

Suzhou-China based Cstone Pharmaceuticals, which in-licensed RET inhibitor pralsetinib from Blueprint Medicines in 2018, has won Chinese approval for the drug to treat adult patients with locally advanced or metastatic RET fusion-positive non-small-cell lung cancer after platinum-based chemotherapy. Already approved as Gavreto in the U.S., the drug is Cstone’s first product approved in China and country’s first selective RET inhibitor.

Frontline cemiplimab monotherapy improved overall, PFS for high PD-L1 NSCLC

First-line treatment with cemiplimab (Libtayo) monotherapy significantly improved OS and PFS when compared with chemotherapy for patients with advanced NSCLC and PD-L1 expression on at least 50% of cells, according to data published in The Lancet. The PD-L1 inhibitor monotherapy treatment was studied in the multicenter, open-label, global, randomized Phase 3 EMPOWER-Lung-01 trial, which supported the agent’s approval in February 2021 as a new treatment option for this patient population.

Median OS was not reached (95% CI, 17.9-not evaluable) with cemiplimab compared with 14.2 months (11.2–17.5) with chemotherapy (HR, 0.57; 95% CI, 0.42-0.77]; P = .0002) in the PD-L1 of at least 50% patient population. More, in this same patient population, median PFS was recorded at 8.2 months (95% CI, 6.1-8.8) with cemiplimab treatment compared with 5.7 months (95% CI, 4.5-6.2) with chemotherapy (HR 0.54; 95% CI, 0.43-0.68; P <.0001).

Phase 3 trial of canakinumab for advanced NSCLC misses primary endpoint

A randomized phase 3 trial designed to evaluate canakinumab plus chemotherapy for advanced non-small cell lung cancer failed to meet its primary endpoint of OS, according to the agent’s manufacturer. Canakinumab (ACZ885, Novartis) is a human monoclonal antibody that targets interleukin-1 beta. The CANOPY-2 trial included 237 adults with locally advanced or metastatic NSCLC whose disease progressed on or after platinum-based chemotherapy and immunotherapy with a PD-1/PD-L1 inhibitor.

Results showed the addition of canakinumab to docetaxel as second- or third-line treatment failed to extend OS compared with docetaxel alone. Results of CANOPY-1, which is investigating canakinumab in combination with first-line pembrolizumab and platinum-based doublet chemotherapy, are expected by the end of this year.

Pembrolizumab's indication in small cell lung cancer is withdrawn

Merck announced the company is voluntarily withdrawing the US indication for pembrolizumab Keytruda for the treatment of patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.

The withdrawal of this indication was done in consultation with the US FDA, and Merck is working to complete this process over the coming weeks. This decision does not affect other indications for pembrolizumab. The accelerated approval for pembrolizumab was granted in June 2019 based on tumor response rate and durability of response data from KEYNOTE-158 (cohort G) and KEYNOTE-028 (cohort C1).

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