The US Food and Drug Administration (FDA) has advanced a targeted therapy for ROS1-positive non-small cell lung cancer (NSCLC) and a combination maintenance treatment for extensive-stage small cell lung cancer (ES-SCLC). Both updates represent significant progress in targeted treatments and maintenance therapy for patients with lung cancer.
Taletrectinib is Approved for ROS1-Positive NSCLC
Taletrectinib has received the green light to treat locally advanced or metastatic ROS1-positive NSCLC. The approval is based on findings from the multicenter, single-arm, open-label TRUST-I and TRUST-II clinical trials.
The primary endpoints were confirmed overall response rate (ORR) and duration of response (DOR). For patients who were treatment-naive, the ORR was 90% in TRUST-I and 85% in TRUST-II, with 72% and 63% of responders having a DOR of 12 months or greater, respectively.1 For patients pretreated with a TKI, the ORR was 52% in TRUST-I and 62% in TRUST-II, with 74% and 83% of responders having a DOR of 6 months or longer, respectively.1
Efficacy was evaluated in patients with locally advanced or metastatic ROS1-positive NSCLC.1 The efficacy population included 157 patients who were naïve to treatment with a ROS1 TKI (103 in TRUST-I; 54 in TRUST-II) and 113 patients (66 in TRUST-I; 47 in TRUST-II) who had received one prior ROS1 TKI.1 Patients could have received prior chemotherapy for advanced disease.1
FDA Grants Priority Review to Lurbinectedin Plus Atezolizumab for First-Line Maintenance Treatment of ES-SCLC
The FDA has accepted a supplemental New Drug Application for a combination of lurbinectedin with atezolizumab for ES-SCLC in the first-line setting, according to a press release from Jazz Pharmaceuticals.
The submission was based on findings from the phase III IMforte trial, in which the combination treatment demonstrated statistically significant improvements in progression-free survival (PFS) and overall survival (OS), compared with atezolizumab monotherapy.2
During the trial, patients who didn’t have disease progression after induction therapy with carboplatin, etoposide, and atezolizumab were randomized to receive either the combination therapy or atezolizumab alone.2 Patients who received lurbinectedin and atezolizumab had a median PFS of 5.4 months versus 2.1 months for those who received atezolizumab alone.2
The median OS for patients treated with the lurbinectedin-atezolizumab combination was 13.2 months, compared with 10.6 months for the atezolizumab-only group.2 Treatment with lurbinectedin and atezolizumab lowered the risk of disease progression by 46% and the risk of death by 27% compared with atezolizumab monotherapy.2 Additionally, there were no new or unexpected safety signals reported with the combination treatment.2
The IMforte study is the first positive maintenance trial in ES-SCLC, and the data represent an important milestone in potentially offering patients a first-line maintenance option that could help them live longer without disease progression.
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