What clinops professionals need to know
For clinical operations professionals, the five-year EMPOWER-Lung 3 data reinforce the durability of Libtayo plus chemotherapy as a first-line option for advanced NSCLC without driver mutations. The regimen demonstrated long-term survival benefits, including in squamous patients, with improvements across OS, PFS, ORR, and DoR. These findings support its established regulatory approval and highlight the importance of designing trials that capture durable outcomes across patient subgroups.
Regeneron has shared positive, long-term overall survival (OS) data from the Phase III EMPOWER-Lung 3 clinical trial (NCT03409614), which assessed Libtayo (cemiplimab) along with platinum-based chemotherapy versus chemotherapy alone as a first-line treatment for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with no EGFR, ALK, or ROS1 aberrations.1
Long-term survival outcomes
According to the five-year results, Libtayo plus chemotherapy demonstrated an OS rate of 19.4%, compared to 8.8% with chemotherapy alone. Additionally, this latest analysis revealed notable benefit in the squamous patient population in which median OS was 22.3 months.
In a press release, Ana Baramidze, MD, PhD, head of clinical research department at Todua Clinic, Tbilisi, Georgia, said: “After more than five years of follow-up, the EMPOWER-Lung 3 trial continues to demonstrate sustained survival—with an impressive overall survival probability of 19.4% at five years—when Libtayo is added to chemotherapy in patients with advanced non-small cell lung cancer. Long-term results across tumor histologies were also reported, including a notable 22.3-month median overall survival for squamous NSCLC patients. Collectively, these data underscore Libtayo’s utility across a variety of patient types, both as a single agent and in combination with chemotherapy.”
Study design
The Phase III EMPOWER-Lung 3 study was a randomized, multicenter study that enrolled 466 NSCLC patients.
- Patients were randomized 2:1 to receive Libtayo 350 mg every 3 weeks for up to 108 weeks plus four cycles of platinum-doublet chemotherapy (n=312) or placebo plus chemotherapy (n=154).
- The primary endpoint was OS, with progression-free survival (PFS) and objective response rate (ORR) as key secondary endpoints.
- Baseline characteristics included 43% with squamous histology, 67% with PD-L1 expression <50%, 15% with inoperable locally advanced disease, and 7% with stable brain metastases.
- Most patients (84%) had an ECOG performance status of 1.
Secondary efficacy outcomes
In addition to Libtayo plus chemotherapy’s strong mark in the primary endpoint of OS, other results show:
- Median PFS was 8.2 months with Libtayo plus chemotherapy versus 5.5 months with chemotherapy alone, reflecting a 42% lower risk of progression (HR 0.58; 95% CI: 0.47–0.72).
- ORR was 43.6% versus 22.1%, including complete responses in 6.4% versus 0%.
- Median duration of response (DoR) was 16.4 months compared to 7.3 months.
- Outside of the squamous patient population, Libtayo plus chemotherapy showed consistent survival benefit in:
- Non-squamous histology: median OS 19.4 months versus 12.4 months (HR 0.62; 95% CI: 0.46–0.82).
- PD-L1 ≥1%: median OS 24.0 months versus 12.1 months (HR 0.54; 95% CI: 0.41–0.70).
Regulatory background
Libtayo plus chemotherapy was approved by the FDA in November of 2022 for the first-line treatment of adult patients with advanced NSCLC with no EGFR, ALK or, ROS1 aberrations. The approval was based on earlier results from the EMPOWER-Lung 3 trial.2
An earlier readout from the trial showed:
- Median OS was 22 months with the Libtayo combination versus 13 months with chemotherapy, a 29% reduction in risk of death (HR 0.71; 95% CI: 0.53–0.93; p=0.014).
- The 12-month survival probability was 66% for the Libtayo arm versus 56% for chemotherapy.
- Median PFS was 8 months versus 5 months, representing a 44% lower risk of progression (HR 0.56; 95% CI: 0.44–0.70; p<0.0001).
- The 12-month probability of PFS was 38% with the combination versus 16% with chemotherapy.
- ORR was 43% compared to 23%.
- Median DoR was 16 months (range: 2–19+), versus 7 months (range: 2–19+) with chemotherapy.
References
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