sunitinib / Generic mfg. - LARVOL DELTA

Development and external validation of a new prognostic model for metastatic clear cell renal cell carcinoma: a preregistered analysis using data from randomised clinical trials in the checkpoint inhibitor era. (PubMed, Lancet Oncol) - "The CPI2 model, using 14 readily available clinical parameters, demonstrated improvement in discriminative accuracy compared with the IMDC model. This classification should be further validated in other trial and observational populations and be used to reanalyse heterogeneity of treatment effects of immune checkpoint inhibitor-based combination regimens in trials shaping the current and future treatment landscape."

Checkpoint inhibition • IO biomarker • Journal • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • PD-L1

Transcriptional Regulation of Receptor-Mediated Mitophagy in Sunitinib-Resistant Renal Cancer Cells: Response to Succinic Acid. (PubMed, Pharmaceuticals (Basel)) - "In contrast, the sunitinib + 50 µM succinic acid combination selectively increased PARKIN, PGAM5, LONP1, and ATP5F1A expression in resistant cells (2.49- to 5.98-fold; p < 0.005), a pattern not observed in parental cells. These findings indicate that sunitinib resistance in ACHN cells is associated with upregulated transcription of receptor-mediated mitophagy components and downregulated transcription of PINK1/Parkin pathway genes, and that exogenous succinic acid selectively upregulates PARKIN and other mitochondrial homeostasis-related gene expression in resistant, but not parental, cells."

Journal • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • BNIP3 • LONP1

Real World Study of Effectiveness of Sunitinib or Sorafenib to Chinese Unresectable Locally Advanced or Metastatic PRCC (clinicaltrials.gov) - P=N/A | N=48 | Completed | Sponsor: AstraZeneca | Recruiting ➔ Completed | N=150 ➔ 48

Enrollment change • Real-world evidence • Trial completion • Genito-urinary Cancer • Oncology • Papillary Renal Cell Carcinoma • Renal Cell Carcinoma • Solid Tumor

Converting lysosomes into photothermal organelles enables nanoparticle-free tumor ablation via intracellular vapor bubbles. (PubMed, Sci Adv) - "Using sunitinib, a clinically approved lysosomotropic anticancer drug, and the commercially available dye LysoTracker Deep Red, lacking intrinsic anticancer activity, we demonstrate pulsed laser-induced VB formation from dye-enriched lysosomal compartments, leading to selective photomechanical disruption of various ex vivo cancer cell models across two-dimensional (2D) cultures, 3D spheroids, patient-derived neuroblastoma tumoroids, and tumor fragments from a patient with ovarian carcinoma. This approach allows precise, low-fluence, and wavelength-tunable cancer tissue ablation without the need for synthetic photoresponsive nanoparticles."

Journal • Neuroblastoma • Oncology • Ovarian Cancer • Solid Tumor

Efficacy of IO-based Combinations versus Sunitinib in Bone Metastatic Renal Cell Carcinoma: A Systematic review and Meta-analysis of Phase III Trials with Long-term Follow-up (ESMO 2026) - No abstract available

Metastases • P3 data • Retrospective data • Review • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Efficacy and Safety Profile of Sunitinib in Recurrent High-grade Meningioma at CHUS Fleurimont (ESMO 2026) - No abstract available

Clinical • Brain Cancer • Meningioma • Oncology • Solid Tumor

Cytoreductive radiofrequency ablation plus sunitinib or sunitinib alone in patients with metastatic renal cell carcinoma (mRCC) and small primary tumors: 15-year overall survival from a phase 2 study. (ESMO 2026) - No abstract available

Clinical • Metastases • P2 data • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Phase 3 Peak Crossover: Bezuclastinib + Sunitinib Combination Following Sunitinib Monotherapy in Patients with GIST (ESMO 2026) - No abstract available

Clinical • Monotherapy • P3 data • Oncology • Sarcoma • Solid Tumor

Efficacy and safety of nivolumab monotherapy in patients with unresectable clear cell sarcoma and alveolar soft part sarcoma (OSCAR Trial/NCCH1510). (PubMed, Cancer) - "The primary end point of the ORR was not met for CCS and ASPS on the central review. Further studies are needed to evaluate ICIs in patients with ASPS."

Journal • Monotherapy • Alveolar Soft Tissue Sarcoma • Genito-urinary Cancer • Melanoma • Oncology • Renal Cell Carcinoma • Sarcoma • Solid Tumor • TFE3

Endoscopic Submucosal Dissection and Full-Thickness Resection for Recurrent Rectal GIST: An Organ-Preserving Therapeutic Approach (ACG 2026) - "Imatinib was switched to Sunitinib for tumor recurrence prevention. Standard management includes neoadjuvant therapy and complete resection without rupture given high malignant and recurrence potential; however, resection may require abdominoperineal excision with permanent stoma formation, significantly affecting quality of life. Endoscopic techniques can provide organ-preserving alternatives in selected patients, highlighting the importance of multidisciplinary care and early referral to experienced endoscopists to optimize oncologic and functional outcomes in this rare entity."

Gastric Cancer • Gastrointestinal Disorder • Gastrointestinal Stromal Tumor • Sarcoma • KIT

EUS-RFA for Refractory Recurrent Gastric Gastrointestinal Stromal Tumor: A Novel Therapeutic Approach (ACG 2026) - "Pathology confirmed GIST, and adjuvant imatinib was initiated...Despite sequential therapy with sunitinib and regorafenib, imaging showed recurrent perigastric nodules...Although radiofrequency ablation has been described for metastatic GIST, particularly hepatic lesions, data regarding EUS-RFA for localized recurrent gastric GIST remain limited. Larger studies are needed to evaluate long-term oncologic outcomes and define the role of EUS-RFA in the management algorithm for recurrent GIST."

Stroma • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Gastrointestinal Stromal Tumor • Hematological Disorders • Hepatology • Oncology • Sarcoma • ANO1 • KIT

Progression-Free Survival With Second, Third, and Fourth Line Tyrosine Kinase Inhibitors After Imatinib Failure in Gastrointestinal Stromal Tumors: A Genetic Mutation-Stratified Systematic Review and Meta-Analysis (ACG 2026) - "Masitinib did not improve PFS versus sunitinib. In the VOYAGER trial, avapritinib did not improve progression-free survival compared with regorafenib in the overall study population, but it showed activity in patients with PDGFRA D842V mutations... 11 randomized trials including 2,181 patients with advanced gastrointestinal stromal tumors after imatinib failure were included. Overall, active TKIs significantly improved progression-free survival (PFS) compared with placebo or best supportive care (HR 0.32, 95% CI 0.21â0.51) although heterogeneity was substantial. Sunitinib, regorafenib, ripretinib, pazopanib, and imatinib rechallenge showed benefit in delaying disease progression compared with placebo or best supportive care, whereas Nilotinib did not with best supportive care, with or without imatinib or sunitinib."

Retrospective data • Review • Stroma • Gastrointestinal Stromal Tumor • Oncology • Sarcoma • KIT • PDGFRA

Efficacy and Safety of [177Lu]Lu-DOTATATE Versus High-Dose Somatostatin Analogues in Advanced Gastroenteropancreatic Neuroendocrine Tumors: A Meta-Analysis (ACG 2026) - " 177Lu-Dotatate delivers profound and consistent PFS improvement with a pooled HR of 0.17 - exceeding that of any other systemic therapy in GEP-NETs including everolimus (HR 0.48), sunitinib (HR 0.42), and lanreotide (HR 0.47) - alongside durable tumor responses and a manageable safety profile across diverse GEP-NET populations. Three phase 3 RCTs enrolling 651 patients (NETTER-1, NETTER-2, XT-XTR008-3-01) were included. 177Lu-Dotatate significantly improved PFS (pooled HR 0.17; 95% CI 0.09-0.31; p< 0.00001), ORR (18-43% vs. 1-18%), and DCR (90-95% vs."

Metastases • Retrospective data • Gastrointestinal Neuroendocrine Tumor • Neuroendocrine Tumor • Oncology • Solid Tumor

Final prespecified overall survival (OS) analysis of CLEAR: 4-year follow-up of lenvatinib plus pembrolizumab (L+P) vs sunitinib (S) in patients (pts) with advanced renal cell carcinoma (aRCC). (ASCO 2023) - P3 | " Treatment-naïve pts (n=1069) who had aRCC with a clear-cell component were randomized (1:1:1) to receive: L 20 mg PO QD + P 200 mg IV Q3W; or L 18 mg + everolimus 5 mg PO QD; or S 50 mg PO QD (4 wks on/2 wks off). L+P continues to demonstrate clinically meaningful benefit vs S in OS, PFS, ORR, and CR in the 1L treatment of pts with aRCC at 4-yr follow-up, thus supporting the robustness of the primary analysis data from CLEAR. Clinical trial information: NCT02811861. >"

Clinical • Metastases • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

SWOG S1931 (PROBE): Phase III randomized trial of immune checkpoint inhibitor (ICI) combination regimen with or without cytoreductive nephrectomy (CN) in advanced renal cancer. (ASCO-GU 2022) - P3 | "CARMENA trial demonstrated no change in overall survival with addition of nephrectomy to sunitinib therapy... Eligible patients with primary tumor and metastases are treated with one of the FDA approved ICI based combinations: ipililumab and nivolumab, axitinib and pembrolizumab, or axitinib and avelumab. Cabozantinib + nivolumab and lenvatinib + pembrolizumab combinations are being added into the next amendment...The study hypothesis is that CN will result in improvement in OS outcomes in advanced synchronous RCC post-initial systemic immune checkpoint based combination therapy. With a sample size of 302 eligible, randomized participants (151 per arm) and a one-sided alpha = 0.025, the study has 85% power to detect a 47% improvement in median survival (HR = 0.68; 1/0.68 = 1.47)"

Checkpoint inhibition • Clinical • P3 data • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Characterization of Responses to Lenvatinib plus Pembrolizumab in Patients with Advanced Renal Cell Carcinoma at the Final Prespecified Survival Analysis of the Phase 3 CLEAR Study. (PubMed, Eur Urol) - P3 | "In the phase 3 CLEAR trial, lenvatinib plus pembrolizumab (L + P) showed superior efficacy versus sunitinib in treatment-naïve patients with advanced renal cell carcinoma (aRCC). Shrinkage of target tumors with this combination was long-lasting and was observed in patients irrespective of their disease severity. This trial is registered on ClinicalTrials.gov as NCT02811861."

Journal • Metastases • P3 data • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Survival by Depth of Response and Efficacy by International Metastatic Renal Cell Carcinoma Database Consortium Subgroup with Lenvatinib Plus Pembrolizumab Versus Sunitinib in Advanced Renal Cell Carcinoma: Analysis of the Phase 3 Randomized CLEAR Study. (PubMed, Eur Urol Oncol) - "Lenvatinib plus pembrolizumab showed improved efficacy versus sunitinib for patients with advanced RCC; landmark analyses showed that tumor response by 6 mo correlated with longer OS."

Journal • Metastases • P3 data • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Subgroup analyses of efficacy outcomes by baseline tumor size in the phase 3, open-label CLEAR trial. (ASCO-GU 2024) - P3 | "Clinical Trial Registration Number: NCT02811861 Sponsored by Eisai Inc., Nutley, NJ, USA, and Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA Background: In the primary analysis of the phase 3 open-label CLEAR trial, lenvatinib + pembrolizumab (L+P) showed statistically significant and clinically meaningful improvements in progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) compared with sunitinib (S) in patients (pts) with advanced renal cell carcinoma (aRCC) (Motzer NEJM 2021)... 1069 treatment-naïve pts with aRCC and a clear-cell component were randomized (1:1:1) to: L 20 mg PO QD + P 200 mg IV Q3W; or L 18 mg + everolimus 5 mg PO QD; or S 50 mg PO QD (4 wks on/2 wks off)... In CLEAR, clinically meaningful efficacy with L+P was observed across pts with aRCC irrespective of their baseline tumor sizes. These results support the use of L+P for the 1L treatment of aRCC across pts with both..."

Clinical • P3 data • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma

Biomarker analyses from the phase 3 randomized CLEAR trial: Lenvatinib plus pembrolizumab versus sunitinib in advanced renal cell carcinoma. (PubMed, Ann Oncol) - "Improvements in ORR and PFS for L+P versus sunitinib in aRCC were observed consistently across a range of biomarker subgroups defined using RCC driver mutations, PD-L1, gene expression signatures, and molecular subtypes."

Biomarker • IO biomarker • Journal • Metastases • P3 data • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • BAP1 • KDM5C • PBRM1 • SETD2

Efficacy and safety of first-line immunotherapy in advanced renal cell carcinoma: a systematic review and network meta-analysis. (PubMed, Transl Androl Urol) - "Notably, benmelstobart plus anlotinib achieved the highest ORR [odds ratio (OR): 7.55, 95% CI: 3.99-14.28], followed by pembrolizumab plus lenvatinib (OR: 4.18, 95% CI: 2.29-7.61). Other ICI plus tyrosine kinase inhibitor (TKI) combinations and nivolumab plus ipilimumab also significantly improved OS compared to sunitinib...However, these global rankings from pooled cohorts should not be interpreted as absolute clinical recommendations for all subgroups. Real-world treatment selection must be highly individualized and strictly tailored to the patient's specific International Metastatic RCC Database Consortium (IMDC) risk profile alongside the efficacy-safety trade-off."

Journal • Retrospective data • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • IFNA1 • IL2

Multi-target Drug Discovery for Cancer Therapy: A Contemporary Review. (PubMed, Recent Pat Anticancer Drug Discov) - "MKIs and bispecific antibodies represent transformative modalities in modern oncology, supported by robust clinical evidence and extensive patent activity."

IO biomarker • Journal • Fibrosarcoma • Genito-urinary Cancer • Hepatocellular Cancer • Oncology • Renal Cell Carcinoma • Sarcoma • Solid Tumor • Thyroid Gland Carcinoma • FGFR • RET

Lenvatinib plus pembrolizumab versus sunitinib as first-line treatment of patients with advanced renal cell carcinoma (CLEAR): extended follow-up from the phase 3, randomised, open-label study. (PubMed, Lancet Oncol) - P3 | "Efficacy benefits of lenvatinib plus pembrolizumab over sunitinib were durable and clinically meaningful with extended follow-up. These results support the use of lenvatinib plus pembrolizumab as a first-line therapy for patients with advanced renal cell carcinoma."

Journal • Metastases • P3 data • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Phase II KEYNOTE-B61 study of pembrolizumab (Pembro) + lenvatinib (Lenva) as first-line treatment for non-clear cell renal cell carcinoma (nccRCC) (ESMO 2022) - P2 | "Background In ccRCC, first-line pembro + lenva improved OS, PFS, and ORR vs sunitinib in the phase 3 KEYNOTE-581 study. Table: 1448O Conclusions In this preliminary analysis, pembro + lenva showed promising antitumor activity and manageable safety in pts with advanced nccRCC. No new safety signals emerged with this combination."

Clinical • P2 data • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Target Attainment and Clinical and Biochemical Parameters Associated with the Pharmacokinetics of 12 Tyrosine Kinase Inhibitors. (PubMed, Clin Pharmacokinet) - "Target attainment was suboptimal for most TKIs, supporting the need for TDM-guided optimisation and individualised dosing. Associations between TKI exposure and renal, hepatic, and haematological parameters further support personalised treatment strategies."

Journal • PK/PD data • Hematological Disorders • Oncology

Biomarker analyses in patients with advanced renal cell carcinoma (aRCC) from the phase 3 CLEAR trial. (ASCO 2024) - P3 | "Background: In the primary analysis of CLEAR, lenvatinib + pembrolizumab (L+P) significantly improved efficacy vs sunitinib (S) in treatment-naïve patients with aRCC (Motzer 2021). The superiority of L+P vs S in ORR does not appear to be impacted by gene-expression signatures for tumor-induced proliferation, angiogenesis, hypoxia, MYC, or WNT, or by PD-L1 status, TMB/INDEL burden or mutation status of RCC driver genes."

Biomarker • Clinical • IO biomarker • Metastases • P3 data • Tumor mutational burden • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • BAP1 • KDM5C • PBRM1 • PD-L1 • SETD2