Anniko (penpulimab-kcqx)

The patient subsequently received adjuvant treatment with immunotherapy (penpulimab) combined with chemotherapy, followed by penpulimab maintenance therapy, resulting in a progression-free survival of >44 months...Third, it explores the clinical implications of the KRAS mutation in this unique tumor subtype. The overarching goal of this exploration is to offer valuable clinical guidance for managing this rare and understudied subtype of lung cancer, particularly in the context of multimodal therapy involving immunotherapy.

This prospective exploratory phase 2 study employed a three-cohort, two-phase design to evaluate the potential of anlotinib as a substitute for cisplatin in gemcitabine-penpulimab combinations for metastatic nasopharyngeal carcinoma (NPC) patients who were previously treated with cisplatin-based chemoradiotherapy. The GAP regimen demonstrated a favorable safety and efficacy profile, compared to the GP-PA and GP-P regimens in patients with metastatic NPC. These findings suggest that substituting cisplatin with anlotinib may offer a viable therapeutic strategy for this patient population.

P2, N=47, Completed, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Recruiting --> Completed | N=90 --> 47 | Trial completion date: May 2024 --> May 2025 | Trial primary completion date: Oct 2023 --> May 2025

P1/2, N=72, Recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Not yet recruiting --> Recruiting

P2, N=120, Not yet recruiting, West China Hospital

P=N/A, N=33, Recruiting, Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology; Tongji Hospital, Tongji Medical College of Huazhong Universi

P2, N=51, Not yet recruiting, Hunan Cancer Hospital; Hunan Cancer Hospital

P2, N=59, Active, not recruiting, Sun Yat-sen University | N=110 --> 59 | Trial completion date: Oct 2025 --> Jul 2026 | Trial primary completion date: Oct 2024 --> Jul 2025 | Not yet recruiting --> Active, not recruiting

The present study aimed to establish a penpulimab-resistant model, delineate anti-PD-1 resistance traits via single-cell RNA sequencing, and unravel the precise mechanisms through which anlotinib-an anti-angiogenic agent-mitigates penpulimab resistance. Identifying Apoe⁺ M2 macrophages, Srgn⁺ M1 macrophages, and Cxcl2⁺ T cells provides key cellular and molecular targets for developing clinically actionable immunotherapies. Taken together, this work validates the preclinical potential of anlotinib combined with immunotherapy for immunotherapy-resistant tumors.

P2, N=65, Completed, Hunan Cancer Hospital | Recruiting --> Completed | Trial completion date: Dec 2023 --> Apr 2025 | Trial primary completion date: Jun 2023 --> Jan 2025

P1/2, N=194, Recruiting, Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. | N=134 --> 194

Toripalimab and penpulimab significantly improve outcomes in RM-NPC. Their use is anticipated to expand into additional settings and malignancies as research matures.