ACTIVE support for adding apatinib to gefitinib for EGFR-mutated NSCLC
medwireNews: Chemotherapy-naïve patients with nonsquamous non-small-cell lung cancer (NSCLC) and EGFR-activating mutations derive prolonged progression-free survival (PFS) from the addition of apatinib to gefitinib, phase 3 ACTIVE data show.
Presenting the findings at the ESMO Virtual Congress 2020, Li Zhang (Sun Yat-sen University Cancer Center, Guangzhou, China) said: “Apatinib combined with gefitinib is expected to become a new first-line treatment option for EGFR-mutant NSCLC.”
Over a median 15.8-month follow-up, the median PFS, as assessed by independent radiology review committee, was 13.7 months among the 157 patients who were randomly assigned to receive the VEGFR–TKI apatinib 500 mg/day alongside gefitinib 250 mg/day. This was significantly longer than the 10.2-month PFS among the 156 patients who received gefitinib alone.
The corresponding median PFS for each treatment arm as per investigator assessment was 13.8 months and 12.0 months, significantly favoring the combination arm.
The apatinib–gefitinib duo was also associated with a significantly better median duration of response than gefitinib alone, at 12.9 versus 9.3 months, and a significantly greater proportion of patients had a depth of response of 30% or more (89.2 vs 79.5%) and 50% or more (64.3 vs 52.6%).
Zhang highlighted, however, that the objective response rates and disease control rates were “similar” between the two treatment groups, at 77.1% versus 73.7% and 84.7% versus 87.8%, respectively.
In a subgroup analysis according to mutation status at baseline, participants with a mutation in exon 8 of TP53 derived significant PFS benefit from the combination treatment over monotherapy, with a hazard ratio (HR) of 0.24. The same was true for individuals with exon 19 deletions in EGFR, with a HR of 0.67.
Zhang added that a “similar T790M resistance pattern was found in both groups,” with a respective 37.8% and 37.0% of patients taking gefitinib with apatinib and gefitinib alone developing resistance.
The presenter reported that “apatinib plus gefitinib were generally well tolerated with manageable toxicities.”
A total of 84.1% of the apatinib plus gefitinib-treated patients experienced a grade 3 or higher treatment-emergent adverse event (TEAE), compared with 37.7% of patients treated with gefitinib alone. The most common TEAEs associated with the combination were hypertension (46.5%), followed by proteinuria (17.8%), increased ALT (11.5%), and decreased weight (11.5%).
Over half (59.9%) of the patients taking the combination therapy had a dose interruption due to TEAEs and 48.4% had a dose reduction. TEAEs were also associated with the discontinuation of treatment in 5.1% of patients and the death of 7.6% of patients.
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