MedPath

Anlotinib

Generic Name
Anlotinib
Drug Type
Small Molecule
Chemical Formula
C23H22FN3O3
CAS Number
1058156-90-3
Unique Ingredient Identifier
GKF8S4C432
Background

Anlotinib has been investigated for the treatment of Non-small Cell Lung Cancer and Metastatic Colorectal Cancer.

Indication

用于治疗非小细胞肺癌、结直肠癌、肾癌、软组织肉瘤、甲状腺癌、胃癌等。

用于无法手术的局部晚期或转移性甲状腺髓样癌患者的治疗。

Sylvester Comprehensive Cancer Center to Present Groundbreaking Research at ASCO 2025 Annual Meeting

• Researchers from Sylvester Comprehensive Cancer Center will deliver 9 oral presentations, 4 rapid oral presentations, and 51 poster presentations at the upcoming ASCO 2025 Annual Meeting, showcasing significant advances across multiple cancer types. • Highlighted studies include the ADVANCE clinical trial examining novel multiple myeloma treatments, innovative virtual reality interventions for stem cell transplant patients, and groundbreaking research on alcohol-related cancer mortality in the US. • The extensive research portfolio demonstrates Sylvester's leadership in developing cutting-edge cancer therapies, addressing health disparities, and improving supportive care for diverse patient populations.

Promising Pipeline for Soft Tissue Sarcoma Treatment Expands with 130+ Therapies in Development

• Global soft tissue sarcoma pipeline constitutes 125+ companies developing 130+ treatment therapies, with significant progress in clinical trials across various stages of development. • FDA grants Orphan Drug Designation to Actuate Therapeutics' elraglusib for soft tissue sarcoma treatment, highlighting its potential to address unmet needs in this rare cancer. • Novel approaches include tumor-targeting antibody-cytokine fusion proteins, intratumoral administration techniques, and GSK-3β inhibition, offering hope for improved outcomes in this challenging disease.

Golidocitinib Plus PD-1 Antibodies Shows Promise in NSCLC Patients After Anti-PD-1 Therapy Failure

• Dizal's JAK1 inhibitor golidocitinib combined with PD-1 antibodies achieved a 44.3% objective response rate in non-small cell lung cancer patients who progressed on prior anti-PD-1 therapy. • The combination therapy demonstrated remarkable durability with a median response duration of 20.7 months and a complete response rate of 23.9%, offering potential for patients with limited treatment options. • Clinical findings will be presented at the 2025 European Lung Cancer Congress, with researchers suggesting the combination may overcome resistance mechanisms through JAK/STAT pathway modulation.

Akeso's Gumokimab (IL-17 mAb) Application Accepted for Psoriasis Treatment in China

• Akeso's gumokimab, an IL-17 targeting monoclonal antibody, has its NDA accepted by China's NMPA for treating moderate to severe plaque psoriasis. • Clinical trials showed gumokimab's rapid efficacy, with PASI 75 response rates approaching 96% at week 12 and sustained improvement over 52 weeks. • Safety profiles of gumokimab were comparable to placebo, indicating good tolerability, which addresses the need for safer psoriasis treatments. • Akeso aims to meet diverse patient needs by combining gumokimab with other drugs like ebronucimab, enhancing their autoimmune disease product synergy.

Anlotinib Combined with EGFR-TKIs Shows Promise in Extending Progression-Free Survival in Advanced NSCLC

A phase 2 trial, CTONG-1803/ALTER-LOO1, has demonstrated that combining anlotinib with EGFR-tyrosine kinase inhibitors (EGFR-TKIs) significantly extends progression-free survival (PFS) in patients with advanced non-small cell lung cancer (NSCLC) who have shown gradual, oligo, or potential progression after previous EGFR-TKI treatment. The study reported a median PFS of 9.1 months and a 12-month PFS rate of 38.8%, suggesting a feasible and effective treatment strategy for this patient population.

Anlotinib Maintenance Therapy Shows Promise in Extensive-Stage Small Cell Lung Cancer

• A retrospective study indicates that anlotinib maintenance therapy, particularly when combined with immunotherapy, significantly improves progression-free survival (PFS) and overall survival (OS) in ES-SCLC patients. • The median PFS was 7.2 months for all patients, and the median OS reached 17.6 months, highlighting the potential of anlotinib in prolonging survival in this aggressive cancer. • Combining anlotinib with immunotherapy resulted in a median PFS of 8.2 months and a median OS of 20.1 months, demonstrating a statistically significant improvement compared to anlotinib with chemotherapy. • The study confirms that anlotinib-related adverse events are manageable, with no unexpected toxicities or treatment-related deaths, supporting its safety profile in ES-SCLC maintenance therapy.

Lenvatinib-Pembrolizumab Combination Shows Promise as First-Line Treatment for Advanced Renal Cell Carcinoma

Network meta-analysis presented at the 2024 ASCO GU Symposium demonstrates that lenvatinib plus pembrolizumab combination therapy shows comparable overall survival and improved progression-free survival compared to standard treatments for advanced renal cell carcinoma. The findings strengthen the position of this combination therapy in the frontline treatment landscape for kidney cancer.

Sino Biopharm's Benmelstobart Plus Chemotherapy Shows Superior PFS in Phase III NSCLC Trial

• Sino Biopharmaceutical's Benmelstobart, combined with chemotherapy and Anlotinib, significantly prolonged progression-free survival (PFS) in advanced squamous NSCLC patients compared to Tislelizumab plus chemotherapy. • The Phase III trial (TQB2450-III-12) met its primary endpoint, with the Independent Data Monitoring Committee (IDMC) confirming the superiority of the Benmelstobart regimen. • Sino Biopharmaceutical has obtained written consent from China's CDE to submit a marketing application for this new first-line indication, marking the 6th indication for Benmelstobart. • Safety data from the study were consistent with known risks, and detailed results will be presented at an upcoming international academic conference.

Belzutifan Plus Cabozantinib Shows Promise as First-Line Treatment for Advanced Clear Cell Renal Cell Carcinoma

• The combination of belzutifan and cabozantinib demonstrates promising antitumor activity in treatment-naive patients with clear cell renal cell carcinoma (ccRCC). • In the LITESPARK-003 trial, the objective response rate was 70%, with a disease control rate of 98% at a median follow-up of 24.3 months. • The combination therapy showed manageable toxicity, with the most common grade 3-4 treatment-related adverse events being hypertension, anemia, and fatigue. • These findings support further randomized trials to evaluate belzutifan in combination with other tyrosine kinase inhibitor-based regimens for ccRCC.

Camrelizumab and Apatinib Show Promise in Neoadjuvant Treatment of TNBC

• Camrelizumab plus chemotherapy significantly improved pathologic complete response (pCR) rates in early or locally advanced triple-negative breast cancer (TNBC). • Apatinib combined with sintilimab and chemotherapy demonstrated a high pCR rate of 70.6% in early TNBC, suggesting synergistic effects. • Both camrelizumab and apatinib regimens exhibited manageable safety profiles, supporting their potential as new neoadjuvant therapeutic options. • Biomarker analysis in the apatinib study identified correlations between immune response and pCR, offering insights for predicting treatment efficacy.

Anlotinib Plus Chemotherapy Shows Promise in Advanced Gastrointestinal Cancers

• A phase II trial (ALTER-G-001) evaluates anlotinib combined with chemotherapy as first-line treatment for advanced gastrointestinal (GI) cancers with unresectable liver metastasis. • In patients with stage IV colorectal cancer (CRC), anlotinib plus CAPEOX regimen demonstrated encouraging objective response rate (ORR) and disease control rate (DCR). • For GI cancers other than CRC and ESCC, anlotinib combined with standard-of-care chemotherapy also showed promising ORR and DCR, warranting further investigation. • The combination therapy exhibited manageable safety profiles, with adverse events being monitored and managed according to established guidelines.

Toripalimab Plus Chemotherapy Improves Survival in Lung Cancer

• A phase III trial showed that adding toripalimab to chemotherapy significantly improved progression-free survival in extensive-stage small cell lung cancer. • The combination of toripalimab and chemotherapy also led to a statistically significant improvement in overall survival compared to chemotherapy alone. • Genomic analysis identified potential biomarkers, such as mutations in the FA-PI3K-Akt and IL-7 signaling pathways, associated with improved outcomes with toripalimab. • The addition of toripalimab to chemotherapy showed an acceptable safety profile, supporting its use as a new treatment option.

Innovent Highlights Promising Clinical Data on Novel Oncology Molecules at ESMO Asia 2024

• Innovent Biologics is set to present clinical data on multiple novel oncology molecules at the ESMO Asia Congress 2024, showcasing its commitment to innovative cancer therapies. • Updated Phase 1 results of IBI343, a TOPO1i CLDN18.2 ADC, will be presented, demonstrating encouraging efficacy and safety in previously-treated pancreatic cancer patients. • Additional studies feature combinations of sintilimab with chemotherapy and other agents, targeting various cancers including colorectal, liver, and non-small cell lung cancer. • Innovent's robust pipeline and advanced technology platforms in immuno-oncology and antibody-drug conjugates aim to transform cancer treatment options for patients worldwide.

Innovent Highlights IBI343 Data in Pancreatic Cancer at ESMO Asia 2024

• Innovent will present clinical data on novel oncology molecules at the ESMO Asia Congress 2024, showcasing advancements in cancer treatment. • Updated Phase 1 results of IBI343, a TOPO1i CLDN18.2 ADC, will be presented, demonstrating encouraging efficacy and safety in previously-treated pancreatic cancer. • The company is also presenting data on combination therapies involving sintilimab and anlotinib in various cancer types, including colorectal and lung cancer. • Innovent is dedicated to transforming cancer treatment by delivering innovative, effective, and safe therapeutic options for doctors and patients.

China's NMPA Accepts Penpulimab Plus Anlotinib for First-Line Advanced HCC

• China's NMPA has accepted a supplemental new drug application (sNDA) for penpulimab plus anlotinib for first-line treatment of advanced hepatocellular carcinoma (HCC). • The sNDA is based on the phase 3 APOLLO/ALTN-AK105-III-02 study, which showed improved progression-free survival (PFS) and overall survival (OS) compared to sorafenib. • Patients treated with the combination experienced a median PFS of 6.9 months vs 2.8 months with sorafenib, and a median OS of 16.5 months vs 13.2 months, respectively. • The combination therapy demonstrated a manageable safety profile, offering a potentially more effective solution for patients with advanced HCC.

China's NMPA Accepts NDAs for Lung and Liver Cancer Therapies

• Hansoh Pharmaceutical's Aumolertinib NDA was accepted for first-line treatment of NSCLC with EGFR mutations, marking its fifth indication. • Akeso's Penpulimab sNDA was accepted for first-line treatment of advanced hepatocellular carcinoma, based on positive Phase III trial results. • The Penpulimab combination therapy showed significant improvements in PFS and OS compared to sorafenib in HCC patients. • These regulatory acceptances highlight advancements in targeted therapies and immunotherapies for prevalent cancers in China.

Benmelstobart Plus Anlotinib and Chemotherapy Shows Promise in Advanced Esophageal Cancer

• A Phase II trial of benmelstobart, anlotinib, and chemotherapy showed a median progression-free survival of 14.9 months in advanced esophageal cancer patients. • The combination therapy achieved an objective response rate of 72% and a disease control rate of 84% in the intention-to-treat population. • Common adverse events included leukopenia, neutropenia, anemia, and hypertension, with manageable safety profiles overall. • The study suggests this regimen could be a potential first-line treatment option, particularly for patients without liver metastases.

Sintilimab Plus Anlotinib and Chemotherapy Shows Promise in Resectable NSCLC

• A study of 45 patients with resectable non-small cell lung cancer (NSCLC) showed a pathological complete response (pCR) rate of 57.8% with neoadjuvant sintilimab, anlotinib, and chemotherapy. • The objective response rate (ORR) was 71.1%, and the disease control rate (DCR) reached 97.8%, indicating significant tumor regression and disease stabilization in the intention-to-treat population. • Treatment-related adverse events were manageable, with the most frequent being hematologic and gastrointestinal, and immune-related adverse events occurring in a subset of patients. • Analysis of the tumor microenvironment revealed vascular normalization and increased infiltration of immune cells, suggesting a favorable modulation of the tumor milieu by the neoadjuvant regimen.

Benmelstobart Plus Anlotinib Shows Promise in EGFR-Mutated NSCLC After TKI Failure

• A chemotherapy-free regimen of benmelstobart plus anlotinib demonstrated efficacy and low toxicity in Chinese patients with EGFR-positive advanced NSCLC who progressed after EGFR TKI therapy. • The combination therapy achieved a median progression-free survival (mPFS) of nine months, indicating potential as a new immunotherapy option for this population. • The study reported a disease control rate (DCR) of 87.3% and a median duration of response (mDoR) of 19.8 months, suggesting durable responses in patients who responded to the treatment. • Preliminary data showed a median overall survival (mOS) of 28.9 months, which is promising compared to historical data, and a favorable safety profile compared to chemotherapy-containing regimens.

Anlotinib Plus Penpulimab Shows Promise in Advanced Hepatocellular Carcinoma

• The Phase III APOLLO study demonstrated that anlotinib combined with penpulimab significantly improved progression-free survival in patients with advanced hepatocellular carcinoma. • Overall survival was also significantly extended with the anlotinib-penpulimab combination compared to sorafenib, marking a notable advancement in HCC treatment. • The combination therapy showed a manageable safety profile, with treatment-related adverse events comparable to those observed with sorafenib alone. • Conducted in China, the study's findings suggest a potential new treatment option for HCC, particularly in populations with hepatitis B-related liver cancer.
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