Addition of bevacizumab to carboplatin/pemetrexed beneficial in advanced non-small cell lung cancer
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The Food and Drug Administration (FDA) has recommended that ImmunoGen, Inc. conduct a new phase 3 randomized trial to evaluate the safety and efficacy of mirvetuximab soravtansine (IMGN853) in patients with high folate receptor alpha (FRα)-positive, platinum-resistant ovarian cancer.
The approval was based on data from the IMpower 150 trial, an open-label study involving 1202 patients with stage IV metastatic NSq NSCLC who had not received prior chemotherapy for metastatic disease, but could have received prior EGFR or ALK kinase inhibitor if appropriate, regardless of PD-L1 or T-effector gene status and ECOG performance status 0 or 1.
Mirvetuximuab soravtansine uses a humanized FRα-binding antibody to target antibody-drug conjugates specifically to FRα-expressing cancer cells and a potent anti-tumor agent, DM4, to kill the targeted cancer cells.
Study patients who received Avastin plus chemotherapy followed by Avastin alone, had a greater median PFS vs patients who received chemotherapy alone (18.2 months vs 12 months; hazard ratio [HR] 0.62, 95% CI, 0.52-0.75; P<.0001).
According to the authors, this is the first study to identify medications most commonly reported for a specific adverse reaction using this database.
REACH-2 was a randomized, double-blind, placebo-controlled trial that enrolled 292 patients with hepatocellular carcinoma (HCC) who were intolerant to, or had disease progression while on or following treatment with sorafenib and had a high alpha-fetoprotein (AFP-High) defined as AFP ≥400ng/mL.
In the most recent and exhaustive reviews, bevacizumab was not associated with an increase in the risk of systemic adverse events compared with ranibizumab. In patients with age-related macular degeneration, ranibizumab may be associated with increased risk of nonocular hemorrhage compared with control treatments.
The researchers found that the hazard ratio for progression-free survival was 0.74 and 0.83 for atezolizimab plus bevacizumab versus sunitinib in PD-L1+ patients and intention-to-treat patients, respectively.
After completion of the initial bevacizumab treatment cycle, there was a significant reduction in epistaxis severity scores and RBC transfusion requirements.