FDA Approves Atezolizumab With Paclitaxel Protein-Bound and Carboplatin for Metastatic NSCLC Without EGFR/ALK Aberrations
On December 3, 2019, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq®) in combination with paclitaxel protein-bound and carboplatin for the first-line treatment of adult patients with metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.
Efficacy was evaluated in IMpower130 (NCT02367781), a multicenter, randomized (2:1), open-label trial in patients with stage IV non-squamous NSCLC who had received no prior chemotherapy for metastatic disease, but could have received prior EGFR or ALK kinase inhibitor, if appropriate. The trial randomized 724 patients (ITT) to receive atezolizumab, paclitaxel protein-bound, and carboplatin, followed by single-agent atezolizumab or to receive paclitaxel protein-bound and carboplatin, followed by maintenance pemetrexed at the investigator’s discretion (control).
The primary efficacy outcome measures were progression-free survival (PFS) by RECIST v1.1 and overall survival (OS) in the subpopulation of patients documented to have no EGFR or ALK genomic tumor aberrations (ITT-WT). In the primary analysis population (ITT-WT, N = 681), the estimated median PFS was 7.2 months (95% CI: 6.7, 8.3) for the atezolizumab arm compared to 6.5 months (95% CI: 5.6, 7.4) for the control arm(HR 0.75; 95% CI: 0.63, 0.91; p = 0.0024). Median OS were 18.6 months (95% CI: 15.7, 21.1) and 13.9 months (95% CI: 12.0, 18.7), respectively (HR 0.80; 95% CI: 0.64, 0.99; p = 0.0384).
The most common adverse reactions (reported in ≥ 20% of patients) of atezolizumab when administered in combination with other antineoplastic drugs in patients with NSCLC and SCLC were fatigue/asthenia, nausea, alopecia, constipation, diarrhea, and decreased appetite.
The recommended atezolizumab dose for this use is 1200 mg as an IV infusion every three weeks. When atezolizumab is administered on the same day as chemotherapy, atezolizumab should be given first.
View full prescribing information for atezolizumab (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761034s021lbl.pdf).
Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm) or by calling 1-800-FDA-1088.
For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate (https://www.fda.gov/about-fda/oncology-center-excellence/project-facilitate) at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov (mailto:OncProjectFacilitate@fda.hhs.gov).
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