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An Open-Label, Single-Arm, Phase II Trial of Sintilimab Plus Anlotinib for Metastatic Non-Small Cell Lung Cancer
Xun Shi1, Chen Lin1, Lishu Lou1
1Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences, Hangzhou, China.
Background:
Although immune checkpoint inhibitors (ICIs) have markedly improved first-line management of non-small cell lung cancer (NSCLC), many tumors eventually escape control after anti-PD-(L)1 therapy, leaving a clear therapeutic gap. Preclinical studies and preliminary clinical data suggest that coupling ICIs with anti-angiogenesis therapy can yield complementary antitumor effects. Consequently, we launched this investigation to evaluate the therapeutic benefit and tolerability of sintilimab, a PD-(L)1-blocking monoclonal antibody, together with the oral multi-target anti-angiogenesis agent anlotinib in metastatic NSCLC individuals experiencing progression after first-line PD-(L)1 inhibition.
Methods:
At Zhejiang Cancer Hospital, we conducted a phase II trial, single-arm, open-label investigation (registration No. NCT04691388). Patients were adults diagnosed with metastatic NSCLC whose disease had advanced after PD-(L)1 blockade; they received sintilimab plus anlotinib on a 21-day cycle. Investigator-assessed objective response rate (ORR) served as the principal efficacy endpoint.
Results:
Between March 2021 and January 2024, twenty-nine individuals were recruited (median age 63, range 45-74, 96.6% male). Tumor assessment identified five partial responses (PR) (17.2%), nineteen cases of stable disease (SD) (65.5%) and three progressions (10.3%), yielding an ORR of 17.2% and a disease-control rate (DCR) of 82.8%. The cohort's median progression-free survival (PFS) measured 5.0 months (90% CI, 4.2-7.3), and 41.1% of participants remained progression-free at six months. Overall survival reached a median of 15.1 months (90% CI, 8.6-not yet reached), with an 18-month survival proportion of 44.8%. Grade ≥ 3 treatment-related toxicity was dominated by hypertension, occurring in 10.3% of participants; no patient discontinued therapy or died because of drug-related events.
Conclusion:
Sintilimab combined with anlotinib exhibited favorable antitumor activity and tolerable toxicity in post-anti-PD-(L)1 therapy of metastatic NSCLC patients, supporting further randomized controlled trials.
Trial Registration:
ClinicalTrials.gov: NCT04691388. Registered December 31, 2020.
Insights
This study shows sintilimab plus anlotinib offers promising antitumor activity and manageable side effects for metastatic non-small cell lung cancer (NSCLC) patients who progressed on prior anti-PD-(L)1 therapy.
Area of Science:
- Oncology
- Immunotherapy
- Medical Oncology
Background:
- Immune checkpoint inhibitors (ICIs) improved first-line non-small cell lung cancer (NSCLC) treatment, but acquired resistance leads to therapeutic gaps.
- Combining ICIs with anti-angiogenesis agents may offer synergistic antitumor effects.
- Evaluating novel combination therapies is crucial for overcoming resistance in metastatic NSCLC.
Purpose of the Study:
- To assess the efficacy and safety of sintilimab plus anlotinib in metastatic NSCLC patients with prior anti-PD-(L)1 progression.
- To determine the objective response rate (ORR) and disease control rate (DCR) of this combination therapy.
- To evaluate progression-free survival (PFS) and overall survival (OS) in the studied patient cohort.
Main Methods:
- A single-arm, open-label, phase II clinical trial (NCT04691388) was conducted.
- Metastatic NSCLC patients progressing after first-line anti-PD-(L)1 therapy received sintilimab and anlotinib.
- Investigator-assessed ORR was the primary efficacy endpoint; PFS and OS were secondary endpoints.
Main Results:
- The combination therapy achieved an ORR of 17.2% and a DCR of 82.8% in 29 participants.
- Median PFS was 5.0 months, with 41.1% progression-free at 6 months.
- Median OS was 15.1 months, with 44.8% survival at 18 months. Hypertension was the most common grade ≥3 toxicity (10.3%).
Conclusions:
- Sintilimab plus anlotinib demonstrates favorable antitumor activity and acceptable tolerability in post-anti-PD-(L)1 metastatic NSCLC.
- This combination represents a potential therapeutic option for patients with acquired resistance to immunotherapy.
- Further investigation through randomized controlled trials is warranted to confirm these findings.
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