Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen, Royalty - LARVOL DELTA

The efficacy of immunotherapy in alveolar soft part sarcoma (ASPS): A case report (ASH 2025) - "Informed by prior pediatric ASPS studies, his initial treatment regimen consisted of axitinib and pembrolizumab, a TKI and ICI respectively...In the setting of worsening disease/evolving mixed response, the patient was transitioned to a similar regimen of atezolizumab and cabozantinib...By analyzing this patient's unique ASPS tumor characteristics, it became possible to develop a targeted and effective treatment approach. Overall, this case supports the synergistic effect of TKIs and ICIs on ASPS while highlighting their limited side effect profile, suggesting an opportunity for future studies on combinations of immunotherapies."

Case report • Clinical • IO biomarker • Alveolar Soft Tissue Sarcoma • Cough • Respiratory Diseases • Sarcoma • Solid Tumor • ASPSCR1 • PD-L1 • TFE3

Challenges in management of dyspnea at the End-of-life - A Young Oncologist case report. (ESMO Asia 2025) - "This case represents an interesting scenario that highlights that decision-making regarding cessation of anti-cancer treatment by the non-oncologist might be justified in resource-constrained settings where access to oncology services remains limited. Medical issues encountered also point towards the need for adopting a rational and balanced approach towards symptom management at the end of life, when internal medicine skills may be considered indispensable to the provision of specialist palliative care."

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

Genomic landscape of advanced non-small cell lung cancer (aNSCLC) using circulating tumor DNA (ctDNA) next generation sequencing (NGS): A single-center analysis in Taiwan (TW) (ESMO Asia 2025) - "2021, pt was initiated on Crizotinib therapy, and achieved partial response (PR)... In this single-center study of aNSCLC pts in TW, ctDNA NGS identified genomic alts in more than three-quarters of cases with a swift mTAT, supporting its use to guide treatment decisions."

Biomarker • Circulating tumor DNA • Clinical • Metastases • Next-generation sequencing • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • KRAS • PIK3CA • ROS1 • TP53

Drug utilisation evaluation of oral anticancer therapy in a south indian cancer centre (ESMO Asia 2025) - "Among targeted therapies, Gefitinib, Osimertinib, Crizotinib, Afatinib, Lorlatinib, and Nilotinib demonstrated consumption of 30 DDDs per patient over 30 days. Lower consumptions were observed with Lenvatinib and Cabozantinib with 13.3 DDDs and 11.25 DDDs per patient respectively. In the hormonal therapy group, Letrozole, Tamoxifen, Bicalutamide, Anastrozole, Enzalutamide, and Exemestane were all prescribed in line with WHO standards (30 DDDs per patient), whereas Abiraterone exhibited lower consumption of 15 DDDs per patient. Prescribing patterns and consumption metrics were largely consistent with WHO criteria, indicating rational oral anticancer drug use. Prescribing patterns and consumption metrics were largely consistent with WHO criteria, indicating rational oral anticancer drug use. Dose deviations occurred, though reasons were unclear and may relate to adverse effects, indication-specific or patient factors, or economic constraints. Further research is warranted..."

Oncology • Oral Cancer

Long term real-world outcomes of first-line immunotherapy (IO) and vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI) combination in metastatic clear cell renal cell carcinoma (mRCC): Does the type of IO or VEGF-TKI matter? (ESMO Asia 2025) - "Background: First-line treatment of mRCC involves a combination of IO with a VEGF-TKI, or dual IO using nivolumab + ipilimumab...31 (60%) patients received nivolumab and 21 pembrolizumab, while the VEGF-TKI was lenvatinib in 34 (65%) and axitinib in 18... The combination of IO and VEGF-TKIs demonstrated robust efficacy in our mRCC cohort, with high ORR, minimal primary progression, and favourable survival. We recommend using IO in combination with a VEGF-TKI, based on availability, side-effects and experience, as no significant differences were observed between individual IO agents or VEGF-TKIs. Grade 3/4 IRAEs may occur, highlighting the need for early detection and timely intervention."

Clinical • Metastases • Real-world • Real-world evidence • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Immune-related adverse events associated with first-line immune checkpoint inhibitors-based therapy for metastatic renal cell carcinoma (ESMO Asia 2025) - "Background: To assess Immune-related toxicity and safety of first-line immune checkpoint inhibitors-based therapy in metastatic renal cell carcinoma (mRCC) patients treated in real-world clinical practice. The retrospective study included data of 194 patients ≥18 years, with verified mRCC, treated with upfront combined immunotherapy, IO-IO (nivolumab + ipilimumab, 94 (48.5%) patients) or immune-targeted therapy, IO-TKI (100 (51.5%) patients: pembrolizumab + axitinib (85 (43.8%)) or lenvatinib (10 (5.2%)), nivolumab + cabozantinib (5 (2.6%)) from 07.07.2019 to 22.10.2024 at Moscow City Hospital named after S.S. Yudin... Real-world practice data confirmed results of randomized trials regarding with irAEs rate and spectrum but demonstrated higher severe and multiple irAEs frequency in mRCC patients treated with upfront immune checkpoint inhibitors-based therapy. IO-IO was associated with higher rate of multiple irAEs and immune-related renal toxicity comparing IO-TKI."

Adverse events • Checkpoint inhibition • Clinical • Metastases • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

COSMIC-312: Study of Cabozantinib in Combination With Atezolizumab Versus Sorafenib in Participants With Advanced Hepatocellular Carcinoma (HCC) Who Have Not Received Previous Systemic Anticancer Therapy (clinicaltrials.gov) - P3 | N=837 | Active, not recruiting | Sponsor: Exelixis | Trial completion date: Dec 2024 ➔ Jul 2026

Trial completion date • Hepatocellular Cancer • Oncology • Solid Tumor

Phase 2 study of cabozantinib (Cabo) combined with ipilimumab (Ipi)/nivolumab (Nivo) and transarterial chemoembolization (TACE) in patients with liver limited unresectable hepatocellular carcinoma (uHCC). (ASCO-GI 2026) - "Funded by UCI Health Chao Family Comprehensive Cancer Center , Exelixis Clinical Trial Registration Number: 04472767 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Clinical • P2 data • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

Combination immunotherapy in Japanese patients with advanced renal cell carcinoma: bridging gaps between clinical trials, real-world evidence, and the potential value of adverse events-a narrative review. (PubMed, Transl Cancer Res) - "Nivolumab plus ipilimumab (NIVO + IPI) and various ICI + TKI regimens (avelumab + axitinib, pembrolizumab + axitinib, nivolumab + cabozantinib, pembrolizumab + lenvatinib) have shown superior efficacy to sunitinib in pivotal trials...TRAEs show promise as prognostic markers in NIVO + IPI but require further validation in ICI + TKI. Prospective multicenter registries with standardized adverse event reporting, coupled with translational studies, are needed to refine regimen selection and personalized therapy."

Adverse events • HEOR • IO biomarker • Journal • Real-world evidence • Review • Genito-urinary Cancer • Kidney Cancer • Non Clear Cell Renal Cell Carcinoma • Oncology • Renal Cell Carcinoma • Solid Tumor

Disparate patterns of disease time burden in patients with HCC on immunotherapy or tyrosine kinase inhibitors. (PubMed, JHEP Rep) - "Patients were classified based on the use of immunotherapy (nivolumab, pembrolizumab, atezolizumab, durvalumab, tremelimumab, and ipilimumab; including monotherapies or combinations) or TKIs (lenvatinib, sorafenib, cabozantinib, and regorafenib)...We demonstrated that immunotherapy was associated with higher DAH compared with tyrosine kinase inhibitor treatment, although this benefit was dampened by the occurrence of immune-related adverse events. These findings have quality-of-life implications and can be used for patient counselling."

Journal • Hepatocellular Cancer • Oncology • Solid Tumor

Understanding the Impact of Cost-Effectiveness Evaluations on Drug Pricing in Japan: A Case Study of Oncology Therapies (ISPOR-EU 2025) - "Eight oncology therapies (Kymriah, Epikinly, Cabometyx, Retevmo, Enhertu, Polivy, Darzquro, Padcev) have completed HTA reports published on the C2H platform. Japan's HTA system actively uses CEA to reassess high-cost oncology drugs. Although several products faced price revisions, the scope and consistency of these impacts vary. Manufacturers must understand the evolving regulatory, reimbursement, and HTA interplay to navigate Japan's market successfully."

Case study • Clinical • Cost effectiveness • HEOR • Pricing

HEALTHCARE UTILITY AND DISEASE BURDEN IN ADVANCED HEPATOCELLULAR CARCINOMA PATIENTS RECEIVING SYSTEMIC THERAPY (AASLD 2025) - "Patients were classified based on the use of immunotherapy (nivolumab, pembrolizumab, atezolizumab, durvalumab, tremelimumab, and ipilimumab; including monotherapies or combinations) or TKI (lenvatinib, sorafenib, cabozantinib, and regorafenib)... Immunotherapy, when compared with TKI, was associated with significantly reduced disease time burden in advanced HCC patients in this real-world cohort. However, this difference was mitigated with the occurrence of irAEs. Our data has important quality of life implications, and may influence patients' decisions for therapy."

Clinical • Metastases • Hepatocellular Cancer • Oncology • Solid Tumor

Disease stabilization in atypical schwannomatosis with BAP1 and PIK3CA mutations treated with olaparib and alpelisib (SNO 2025) - "Her disease progressed rapidly following standard treatments, including temozolomide, doxorubicin, and cabozantinib...It supports the consideration of molecularly guided targeted therapies in rare, treatment-refractory peripheral nerve sheath tumors with atypical or metastatic behavior. Further studies are needed to evaluate the role of precision medicine in managing atypical schwannomatosis and related low-grade spindle cell neoplasms."

Brain Cancer • Cough • Pulmonary Disease • Respiratory Diseases • Solid Tumor • Spindle Cell Sarcoma • BAP1 • PIK3CA

"Real-world treatment patterns and outcomes beyond first-line immune checkpoint inhibition in patients with HCC: Interim results from the prospective national intersectoral cohort study JADE" (DGHO 2025) - P | "BCLC stage at inclusion was B/C/D for 22%/71%/6% of the pts.Of all evaluable pts with ICI treatment, 251 pts (79%) received atezolizumab and bevacizumab (ATZ+BEV), 52 pts (16%) received durvalumab and tremelimumab (DUR+TRE).At database cut for this interim analysis, 73 of 318 pts (23%) received a subsequent 2L yet, in 73 pts (23%) the 1L was still ongoing, or a therapy break was documented, 139 pts (44%) deceased after the 1L and 33 pts (10%) were lost to follow-up. The most frequent 2L regimen was sorafenib (n=51, 70%) followed by cabozantinib and lenvatinib in 9 pts (12%) each.Median progression-free survival (PFS) of first-line ICI therapy was 4.9 months (95% CI 3.9, 5.7) in all evaluable pts and 7.5 months (95% CI 4.7, 13.4) in pts with BCLC stage B. Median PFS of second-line therapy was 3.4 months (95% CI 2.8, 5.3). In real world, ICIs are the new first-line standard of care. Although there is no evidence from phase 3 trials regarding 2L treatment after..."

Checkpoint inhibition • Clinical • HEOR • Real-world • Real-world evidence • Hepatocellular Cancer • Oncology • Solid Tumor

Second-line cabozantinib after failure of immune-based therapy in patients with metastatic renal cell carcinoma: Analysis of the RENIS II registry (EMUC 2025) - "First-line treatment consisted of ipilimumab/nivolumab in 25 patients, and avelumab/axitinib or pembrolizumab/lenvatinib in the remaining 25 subjects...No unexpected serious adverse events were reported during treatment. Conclusions Data from the RENIS registry confirm the effectiveness and safety of cabozantinib in the second-line setting in the real-world clinical practice in the Czech Republic."

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

Restricted Mean Survival Time–Based Comparative Effectiveness of First-Line Immune Checkpoint Inhibitor Combinations in Metastatic Renal Cell Carcinoma (SUO 2025) - " Compared with sunitinib, OS dRMST was 4.15 months (95% CI: 1.86–6.45, p<0.001) for Nivolumab + Cabozantinib (NIVO–CABO), 3.53 (1.43–5.62, p=0.001) for Lenvatinib + Pembrolizumab (LEN–PEM), 2.75 (0.97–4.53, p=0.002) for Nivolumab + Ipilimumab (NIVO–IPI), and 2.68 (0.77–4.58, p=0.005) for Pembrolizumab + Axitinib (PEM–AXI)... RMST-based analysis enables nuanced comparison of ICI regimens in mRCC, highlighting modest OS benefit, greater PFS separation, cost differences, and distinct toxicity burdens. Nivolumab + Cabozantinib demonstrated the greatest OS benefit, while Lenvatinib + Pembrolizumab achieved the highest PFS gain. These findings underscore the importance of integrating multiple treatment attributes—beyond hazard ratios—into personalized treatment decision-making."

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

REVISITING CYTOREDUCTIVE NEPHRECTOMY IN METASTATIC RENAL CELL CARCINOMA: REAL-WORLD EVIDENCE OF SURVIVAL BENEFIT IN THE ERA OF MODERN IMMUNOTHERAPY AND TARGETED THERAPY (SUO 2025) - "Evidence from the Cancer du Rein Metastatique Nephrectomie et Antiangiogéniques (CARMENA) and the Immediate Surgery or Surgery After Sunitinib Malate in Treating Patients with Metastatic Kidney Cancer (SURTIME) trials have questioned the role of CRN...Using relevant ICD-10 codes and CPT codes, cohorts of patients with mRCC receiving any kind of systemic therapy (n= 1776), Axitinib and Pembrolizumab (n= 470), Cabozantinib and Nivolumab (n=774), Lenvatinib and Pembrolizumab (n = 246), and Ipilimumab and Nivolumab (n= 958), were identified... Although the use of CRN in patients with mRCC has steadily declined since 2012, our large-scale real-world analysis demonstrates that CRN is associated with a significant survival benefit in most patients with mRCC receiving contemporary systemic combination therapy. These findings highlight the continued relevance of CRN in well selected patients and underscore the need to revisit CRN in the immunotherapy era with prospective..."

Clinical • HEOR • Metastases • Real-world • Real-world evidence • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Assessment of advanced clear cell renal cancer patients treated with first-line immuno-combinations: A monocentric Latin American experience (EMUC 2025) - "First-line therapies included nivolumab + ipilimumab (63%), pembrolizumab + axitinib (18.5%), and pembrolizumab + lenvatinib (14.8%)...While our findings are generally consistent with international cohorts, the observed differences in age, BMI distribution, and treatment selection underscore the need for regional data. Future research should focus on prospective, multicenter studies with larger sample sizes and longer follow-up to better understand prognostic factors and optimize treatment strategies in this population."

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

Phase II trial of cabozantinib in combination with nivolumab for advanced extrapancreatic neuroendocrine tumors (epNET). (PubMed, Clin Cancer Res) - "Cabozantinib and nivolumab was associated with limited response in patients with epNET. Alternative strategies to enhance the immune response in epNET are needed."

Journal • P2 data • Fatigue • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Solid Tumor • CD14

NCCN Guidelines in nccRCC Weigh New Data for Combinations (Targeted Oncology) - "Moshe C. Ornstein, MD, MA: The lenvatinib/pembrolizumab study was a larger study. The primary end points were the overall response rates [ORRs] which are similar across both studies [and are] in the low 50% [range].2,3 The response rates are similar by histology, acknowledging that patients with chromophobe [histology] were included in KEYNOTE-B61 [NCT01130519] and not included in the cabozantinib/nivolumab study [CA209-9KU; NCT03635892]."

Audio

Second-line therapies of Metastatic Renal Cell Carcinoma (mRCC) after 1st line immune-combinations (ICI-combos) (Meet-URO 33 study) (EMUC 2025) - "According to the ICI-combo type, 36% of patients treated with Pembrolizumab + Axitinib, 32% with Nivolumab + Ipilimumab, 11% with Nivolumab + Cabozantinib and 9% with Pembrolizumab + Lenvatinib started a 2nd line therapy...Drug combinations (Lenvatinib + Everolimus/Belzutifan) rise as emerging therapies, especially in younger and prognostically unfavorable patients. Further survival and response analyses are planned."

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

Intracranial Metastasis of Renal Cell Carcinoma Exhibiting Mullerian Differentiation: A Case Report (SNO 2025) - "The new plan is to stop nivolumab and cabozantinib and to start belzutifan 120 mg daily based on results from a recent clinical trial involving advanced renal cell carcinoma patients. Despite the uniqueness of the pathology of this patient's malignancy, nivolumab, cabozantinib, and radiotherapy appear to reduce the burden of advanced renal cell carcinoma and associated brain metastases, even if from gynecologic/mullerian origin."

Case report • Clinical • Brain Cancer • Genito-urinary Cancer • Gynecologic Cancers • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

High LAG-3 RNA Levels Predict Response, Not Survival, in Metastatic RCC (Targeted Oncology) - "The discordance between response and survival may be explained by the specific immunological profile associated with LAG3. High expression of the gene was linked to a 'complex immunological phenotype' characterized as both inflamed and exhausted, explained Rana McKay, MD...during a presentation of the study."

Audio • Renal Cell Carcinoma

The Association between Combination-Based Immunotherapy and Thrombotic Events in Patients with Metastatic Renal Cell Carcinoma (ASH 2024) - "The IO/IO regimen was defined as ipilimumab plus nivolumab, while the IO/TKI regimen included nivolumab or pembrolizumab combined with a TKI such as axitinib, cabozantinib, or lenvatinib...Conclusion : There was no difference in the risk of venous and arterial thromboembolic events between mRCC patients receiving the IO/IO regimen and those receiving the IO/TKI regimen. However, patients on the IO/IO regimen had an increased risk of mortality compared to those on the IO/TKI regimen."

Clinical • Metastases • Cardiovascular • Genito-urinary Cancer • Hematological Disorders • Ischemic stroke • Myocardial Infarction • Oncology • Renal Cell Carcinoma • Respiratory Diseases • Solid Tumor • Venous Thromboembolism

A comparative study of two surgical robotic systems for perioperative outcomes of robot-assisted radical cystectomy: A propensity score-matched analysis (EMUC 2025) - "First-line therapies included nivolumab + ipilimumab (63%), pembrolizumab + axitinib (18.5%), and pembrolizumab + lenvatinib (14.8%)...No statistically significant associations were observed between BMI >25, BMI >30, or elevated NER and progression or mortality (all p > 0.05). Conclusions Although the small sample size, our findings suggest that perioperative outcomes of RARC using the novel surgical robot system, hinotori, are comparable to those using da Vinci system."

Bladder Cancer • Genito-urinary Cancer • Solid Tumor