Focus V (anlotinib)

P4, N=80, Not yet recruiting, Qiming Wang

Given the retrospective design and potential confounding of this analysis, these findings should be interpreted with caution. Anlotinib-containing regimens showed potential clinical activity in this patient population and warrant further evaluation.

After transient benefit from first-line doxorubicin plus ifosfamide chemotherapy, the disease progressed despite second-line PD-1 inhibitor combined with anlotinib. Treatment was subsequently switched to cadonilimab, a PD-1/CTLA-4 bispecific antibody, in combination therapy, resulting in a progression-free survival of more than 24 months. This outcome appears encouraging compared with previously reported CCS benchmarks; however, given the single-case nature and combined treatment strategy, the specific contribution of cadonilimab should be interpreted with caution.

After which, the patient received two cycles of immunotherapy with durvalumab, and received continued administration with anlotinib; follow-up evaluation revealed a partial response. At present, the patient remains alive with no evidence of disease progression, achieving a progression-free survival of >42 months. The present case report highlights the potential of immunotherapy combined with anti-angiogenic targeted therapy in treating PD-L1-positive mediastinal SC, despite the life-threatening adverse reactions, offering a viable treatment option for similar clinical cases.

Anlotinib demonstrated promising responses with manageable toxicity in a heavily pretreated R/M HNSCC population. Integration of genomic and immune microenvironment features may provide hypothesis-generating insights into patient selection.

The TMEp phase integrated stereotactic body radiotherapy (SBRT), low-dose etoposide, and anlotinib, followed by CI with the programmed death 1 (PD-1)/cytotoxic T lymphocyte antigen 4 (CTLA-4) bispecific antibody cadonilimab and concurrent probiotic supplementation...The TMEp-CI-M platform may enhance the efficacy of immunotherapy in ES-SCLC, enabling durable responses even in patients with brainstem metastases. Although this platform has demonstrated promise across multiple tumor types, further prospective and mechanistic studies are warranted to confirm its clinical utility.

This research pioneers the identification of anlotinib as an ER stress- and autophagy-dependent ICD inducer in HCC. Our comprehensive mechanistic dissection and robust preclinical evidence establish anlotinib's ability to convert immunologically "cold" tumors to "hot" ones through the FGFR-1/ER stress/autophagy/DAMP release axis. The synergy with anti-PD-1 and enhancement by metformin provide a rationale for novel combination strategies to overcome current limitations of targeted-immunotherapy, offering a promising approach to improve response rates in advanced HCC.

EV-derived miR-941 as a key driver of anlotinib resistance via the Keap1/Nrf2 pathway represent a promising non-invasive predictive biomarker and a potential therapeutic target for overcoming resistance in NSCLC.

P2, N=34, Recruiting, Qilu Hospital of Shandong University | Not yet recruiting --> Recruiting

Enrolled patients received 5 cycles of anlotinib (12 mg qd, d1‒14; q3w) plus 6 cycles of nab-paclitaxel (200 mg/m2, q3w), pirarubicin (50 mg/m2, q3w), and cyclophosphamide (500 mg/m2, q3w). Supporting evidence from an exploratory inverse probability of treatment weighting (IPTW) analysis using a real-world cohort receiving chemotherapy alone indicated a potential benefit of the combination over chemotherapy alone. In conclusion, neoadjuvant anlotinib plus chemotherapy demonstrates promising efficacy and manageable safety in HR+/HER2- breast cancer with a high Ki-67 index.

P2, N=49, Completed, Sun Yat-sen University | Recruiting --> Completed

P2, N=70, Completed, Sun Yat-sen University | Recruiting --> Completed | Trial completion date: May 2024 --> Dec 2025 | Trial primary completion date: Mar 2024 --> Oct 2025