KEY TAKEAWAYS
- The REFLECT phase 3 trial aimed to characterize pts with uHCC treated with 1L LEN and achieve varying tumor responses.
- The study revealed that more profound tumor responses (CR and nCR) showed similar mOS, supporting LEN as a standard 1L treatment for uHCC.
The phase 3 REFLECT trial confirmed that lenvatinib (LEN), a targeted cancer drug, was equivalent to sorafenib in overall survival (OS) among patients (pts) with unresectable hepatocellular carcinoma (uHCC).
Amit Mahipal and colleagues aimed to characterize pts enrolled in the REFLECT trial who received first-line (1L) LEN and achieved a complete response (CR), near-complete response (nCR; partial response [PR] with target lesion reduction [TLR] ≥ 75%), or PR with other TLR.
Pts receiving LEN (12 mg/day if body weight (BW) ≥ 60 kg; 8 mg/day if BW < 60 kg) who responded (CR/PR) were analyzed. The mRECIST treatment response was used to assess Tumor responses independently. Respondents were classified based on tumor reduction: CR, near-CR (TLR ≥ 75%), and PR with TLR 50%-<75% or 30%-<50%.
Baseline demographics and disease characteristics were summarized. Median (m) OS and duration of response (DOR) were calculated using the Kaplan-Meier method, with 95% CIs estimated using the Brookmeyer and Crowley method.
The results revealed that 478 pts with uHCC were randomized to LEN, 194 of which had an objective response and were analyzed. 10 pts had a CR, and 184 pts had a PR (nCR, n=49, PR-TLR ≥ 50-< 75%, n=72; PR-TLR ≥ 30-< 50%, n=63).
Baseline demographics and pts characteristics were well balanced. mDOR was 20.3 months for pts with CR, 7.7 months for pts with nCR, 7.3 months for pts with PR-TLR ≥ 50-< 75%, and 3.7 months for pts with PR-TLR ≥ 30-< 50%.
Proportions of pts with DOR ≥ 6, 12, and 18 months were generally higher in pts with CR and nCR vs pts with PR-TLR ≥ 50-< 75% and PR-TLR ≥ 30-< 50%. mOS was 25.4 months for CR and 23.4 months for nCR, higher than other PR groups.
The study concluded that this is the first characterization of pts with uHCC and nCR, showing durable responses irrespective of TLR. Similar mOS for pts with CR and nCR suggests deeper tumor responses may correlate with improved survival, supporting LEN as standard 1L treatment.
The trial was sponsored by Eisai Limited.
Source: https://cslide.ctimeetingtech.com/esmogi24hybrid/attendee/confcal/show/session/3
Clinical Trial: https://www.clinicaltrials.gov/study/NCT01761266
Mahipal A, Cheng AL, Kudo M, et al. (2024). “Characterization of tumor response with lenvatinib (LEN) in patients (pts) with unresectable hepatocellular carcinoma (uHCC) in REFLECT.” Presented at ESMO-GI 2024, (Abstract 168P).
