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53 Diseases |  |
490 Trials |
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490 Trials |  |
8927 News |  |
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- || Keytruda (pembrolizumab) / Merck (MSD)
Enrollment closed: KEYMAKER-U02 Substudy 02A: Substudy 02A: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents in Participants With Programmed Cell-death 1 (PD-1) Refractory Melanoma (MK-3475-02A/KEYMAKER-U02) (clinicaltrials.gov) - Dec 27, 2023
P1/2, N=200, Active, not recruiting, Sponsor: Merck Sharp & Dohme LLC
Recruiting --> Active, not recruiting
- | reozalimab (IBI318) / Eli Lilly, Lenvima (lenvatinib) / Eisai, Merck (MSD)
Trial completion date, Trial primary completion date: The Efficacy and Safety of the Bispecific Anti-PD-1/PD-L1 Antibody IBI318 Combined with Lenvatinib in NSCLC. (clinicaltrials.gov) - Dec 27, 2023
P1, N=120, Recruiting, Sponsor: Hunan Province Tumor Hospital
Recruiting --> Active, not recruiting Trial completion date: Nov 2023 --> Dec 2025 | Trial primary completion date: Aug 2023 --> Dec 2024
- | Avastin (bevacizumab) / Roche, IBI-323 / Innovent Biologics, Alecensa (alectinib) / Roche
Biomarker, Enrollment open, Trial completion date, Trial primary completion date: Efficacy and Biomarker Explanation of IBI-323 + Bevacizumab Plus Platinum Based Chemotherapy on ALK-Rearranged NSCLC (clinicaltrials.gov) - Dec 27, 2023
P2, N=70, Recruiting, Sponsor: Hunan Province Tumor Hospital
Trial completion date: Nov 2023 --> Dec 2025 | Trial primary completion date: Aug 2023 --> Dec 2024 Not yet recruiting --> Recruiting | Trial completion date: Apr 2025 --> Apr 2026 | Trial primary completion date: Dec 2024 --> Dec 2025
- | IBI-363 / Innovent Biologics
Enrollment open, Metastases: Promise: The Efficacy and Safety of IBI363 in Solid Tumors (clinicaltrials.gov) - Dec 27, 2023
P1, N=430, Recruiting, Sponsor: Hunan Province Tumor Hospital
Not yet recruiting --> Recruiting | Trial completion date: Apr 2025 --> Apr 2026 | Trial primary completion date: Dec 2024 --> Dec 2025 Not yet recruiting --> Recruiting
- | JS201 / Shanghai Junshi Biosci, Lenvima (lenvatinib) / Eisai, Merck (MSD)
Trial completion date, Trial primary completion date: JS-201 Combined With Lenvatinib in the Treatment of Small-cell Lung Cancer (clinicaltrials.gov) - Dec 27, 2023
P2, N=30, Recruiting, Sponsor: Hunan Province Tumor Hospital
Not yet recruiting --> Recruiting Trial completion date: Jun 2023 --> Jun 2025 | Trial primary completion date: Jun 2022 --> Jun 2024
- | Lenvima (lenvatinib) / Eisai, Merck (MSD), simridarlimab (IBI-322) / Innovent Biologics
Biomarker, Enrollment open, Trial completion date: Efficacy and Biomarker Explanation of IBI-322 Plus Lenvatinib on Extensive Stage Small Cell Lung Cancer (clinicaltrials.gov) - Dec 26, 2023
P2, N=83, Recruiting, Sponsor: Hunan Province Tumor Hospital
Trial completion date: Jun 2023 --> Jun 2025 | Trial primary completion date: Jun 2022 --> Jun 2024 Not yet recruiting --> Recruiting | Trial completion date: Dec 2024 --> Dec 2025
- Lenvima (lenvatinib) / Eisai, Merck (MSD), Tecentriq (atezolizumab) / Roche
Atezolizumab plus Bevacisumab versus lenvatinib for BCLC-B stage patients with hepatocellular carcinoma : a large real life worldwide population (ePoster Area) - Dec 26, 2023 - Abstract #LCS2024LCS_240;
Not yet recruiting --> Recruiting | Trial completion date: Dec 2024 --> Dec 2025 Although Lenvatinib had a greater response, the study showed no statistically significant differences between Lenvatinib and A+B in terms of efficacy, in these two cohorts of BCLC-B HCC patients.
- fostroxacitabine bralpamide (MIV-818) / Medivir
Population pharmacokinetic modeling of orally administered fostroxacitabine bralpamide (fostrox, MIV-818) and its metabolite troxacitabine in a phase I/IIa liver cancer study (ePoster Area) - Dec 26, 2023 - Abstract #LCS2024LCS_208;
P1/2
Fostrox is in clinical development in combination with lenvatinib in patients with hepatocellular carcinoma (HCC). The PK models described the fostrox and troxacitabine data well with dose linear increase in exposure and linear elimination of both moieties
- Avastin (bevacizumab) / Roche, Lenvima (lenvatinib) / Eisai, Merck (MSD), Tecentriq (atezolizumab) / Roche
A multi-center comparison of Atezolizumab plus Bevacizumab and Lenvatinib as primary systemic therapy for unresectable hepatocellar carcinoma: focus on thrombotic and hemorragic adverse events (ePoster Area) - Dec 26, 2023 - Abstract #LCS2024LCS_204;
AB or Lev had comparable overall survival and disease control rate. In both group thrombotic events were uncommon: therapy with anticoagulants avoided the risk of thrombotic events but increased the hemorrhagic risks.
- Avastin (bevacizumab) / Roche, Tecentriq (atezolizumab) / Roche
?-FAtE: a new predictive score of response to atezolizumab plus bevacizumab for unresectable hepatocellular carcinoma incorporating ?-Fetoprotein, Alkaline phosphatase and Eosinophil count (ePoster Area) - Dec 26, 2023 - Abstract #LCS2024LCS_191;
Background and aims: Atezolizumab plus bevacizumab (A+B) and lenvatinib can be alternatively used as first-line systemic treatment of unresectable hepatocellular carcinoma (HCC). ?FAtE is a novel prognostic and predictive score of response to first-line A+B for HCC patients that, if validated in prospective studies, could drive therapeutic choice between lenvatinib and A+B as first-line systemic treatment.
- Avastin (bevacizumab) / Roche, Tecentriq (atezolizumab) / Roche
The prognostic impact of viral and non-viral etiologies on advanced hepatocellular carcinoma patients treated with atezolizumab plus bevacizumab: a real-world, multicenter study (ePoster Area) - Dec 26, 2023 - Abstract #LCS2024LCS_172;
However, some prognostic factors differ between viral and non-viral patients, with immunological factors being mostly related to the former while metabolic to the latter, supporting potential biological differences. This may also account for different outcomes of A+B observed in comparative studies with lenvatinib in etiology subgroups.
- Avastin (bevacizumab) / Roche, Lenvima (lenvatinib) / Eisai, Merck (MSD), Tecentriq (atezolizumab) / Roche
Lenvatinib (L) versus sorafenib (S) second-line therapy in hepatocellular carcinoma (HCC) patients progressed to atezolizumab plus bevacizumab (AB) (ePoster Area) - Dec 26, 2023 - Abstract #LCS2024LCS_162;
This may also account for different outcomes of A+B observed in comparative studies with lenvatinib in etiology subgroups. L second-line therapy is superior to S in HCC patients progressed to first-line AB.
- Lenvima (lenvatinib) / Eisai, Merck (MSD)
A preliminary collection of healthy and tumoral patient-derived organoids for the screening of personalized therapies in hepatocellular carcinoma (ePoster Area) - Dec 26, 2023 - Abstract #LCS2024LCS_121;
We observed a different sensitivity of HCC organoids to TKIs, supporting the use of PDOs as reliable personalized models for drug screenings. Further genetic and morphological characterization and expansion of the collection will be fundamental to obtain a comprehensive preclinical platform for the study of tailored treatments in HCC.
- sorafenib / Generic mfg.
MiR-22 downregulation activates HIF-1A pathway and induces tumor progression, metabolic reprogramming and sorafenib resistance in hepatocellular carcinoma (ePoster Area) - Dec 26, 2023 - Abstract #LCS2024LCS_112;
Interestingly, miR-22 has an impact on sorafenib sensitivity, possibly via HIF-1A stabilization and glycolytic metabolism. If confirmed in animal models, the use of miR-22 mimics in combination with sorafenib deserves attention for the treatment of HCC patients being ineligible for immunotherapy
- Profile of immune-related adverse events and treatment outcomes in first-line immunotherapy for hepatocellular carcinoma (ePoster Area) - Dec 26, 2023 - Abstract #LCS2024LCS_62;
The median time to the first adverse event that required treatment interruption was 64 days, and in 12.8% of the patients, this adverse event occurred after the first dose of immunotherapy. This data emphasizes the importance of establishing hospital networks for early detection and ensuring timely access to experienced specialists for the management of immune related adverse events.
- Avastin (bevacizumab) / Roche, Lenvima (lenvatinib) / Eisai, Merck (MSD), Tecentriq (atezolizumab) / Roche
Impact of body mass index on the prognosis of unresectable HCC patients receiving first line Lenvatinib or Atezolizumab plus Bevacizumab (ePoster Area) - Dec 26, 2023 - Abstract #LCS2024LCS_56;
This data emphasizes the importance of establishing hospital networks for early detection and ensuring timely access to experienced specialists for the management of immune related adverse events. Our analysis highlighted a prognostic role of BMI in a cohort of patients with advanced HCC who received Atezolizumab plus Bevacizumab, while no prognostic role for low BMI was apparent in patients who received Lenvatinib.
- Lenvima (lenvatinib) / Eisai, Merck (MSD)
Safety and efficacy of lenvatinib in very elderly patients with unresectable hepatocellular carcinoma (ePoster Area) - Dec 26, 2023 - Abstract #LCS2024LCS_32;
Our analysis highlighted a prognostic role of BMI in a cohort of patients with advanced HCC who received Atezolizumab plus Bevacizumab, while no prognostic role for low BMI was apparent in patients who received Lenvatinib. Our study highlights the same efficacy and safety of Lenvatinib between elderly and not elderly patients
- Avastin (bevacizumab) / Roche, Lenvima (lenvatinib) / Eisai, Merck (MSD), Tecentriq (atezolizumab) / Roche
Impact of metformin, statin, aspirin and insulin on the prognosis of unresectable HCC patients receiving first line Lenvatinib or Atezolizumab plus Bevacizumab (ePoster Area) - Dec 26, 2023 - Abstract #LCS2024LCS_22;
Our study highlights the same efficacy and safety of Lenvatinib between elderly and not elderly patients This analysis unveils a negative prognostic role associated with metformin use specifically within the Atezolizumab plus Bevacizumab group.
- Avastin (bevacizumab) / Roche, Lenvima (lenvatinib) / Eisai, Merck (MSD), Tecentriq (atezolizumab) / Roche
Evaluation of glycemia and diabetes as prognostic factors in advanced hepatocellular carcinoma treated with systemic therapy (ePoster Area) - Dec 26, 2023 - Abstract #LCS2024LCS_19;
Our study suggests the lack of an association between hyperglycemia and/or DM and OS among aHCC patients who undergo ST, which is not hampered by coexistent DM/hyperglycemia. Other laboratory findings universally available in clinical practice, such as ALT levels and NLR, were associated with poorer prognosis in the study population
- || Review, Journal, Metastases: LITESPARK-012: pembrolizumab plus lenvatinib with or without belzutifan or quavonlimab for advanced renal cell carcinoma. (Pubmed Central) - Dec 25, 2023
P3
Results from this study may support triplet combination therapies as a potential new standard of care for advanced ccRCC. Clinical trial registry: NCT04736706 (ClinicalTrials.gov).
- ||| Keytruda (pembrolizumab) / Merck (MSD)
Enrollment closed: KEYMAKER-U02 Substudy 02D: Substudy 02D: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With Melanoma Brain Metastasis (MK-3475-02D/KEYMAKER-U02) (clinicaltrials.gov) - Dec 22, 2023
P1/2, N=300, Active, not recruiting, Sponsor: Merck Sharp & Dohme LLC
Clinical trial registry: NCT04736706 (ClinicalTrials.gov). Recruiting --> Active, not recruiting
- | Lenvima (lenvatinib) / Eisai, Merck (MSD)
Journal: An ever-increasing metabolic dysfunction-associated fatty liver disease-related hepatocellular carcinoma: what are problems and countermeasures? (Pubmed Central) - Dec 20, 2023
Recruiting --> Active, not recruiting No abstract available
- |||| Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Trial completion date, Trial primary completion date: CheckMate 9DW: A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma (clinicaltrials.gov) - Dec 20, 2023
P3, N=732, Active, not recruiting, Sponsor: Bristol-Myers Squibb
No abstract available Trial completion date: Jun 2025 --> Sep 2026 | Trial primary completion date: Jun 2025 --> Jul 2026
- | E7386 / Eisai, PRISM Pharma
Phase classification: E7386-J081-102: A Study of E7386 in Combination With Other Anticancer Drug(s) in Participants With Solid Tumor (clinicaltrials.gov) - Dec 19, 2023
P1, N=181, Recruiting, Sponsor: Eisai Inc.
Trial completion date: Jun 2025 --> Sep 2026 | Trial primary completion date: Jun 2025 --> Jul 2026 Phase classification: P1b --> P1
- || Keytruda (pembrolizumab) / Merck (MSD), Lenvima (lenvatinib) / Eisai, Merck (MSD)
Enrollment open: Lenvatinib Plus Pembrolizumab in Well Differentiated G3 Neuroendocrine Tumors (clinicaltrials.gov) - Dec 19, 2023
P2, N=29, Recruiting, Sponsor: University of California, San Francisco
Phase classification: P1b --> P1 Not yet recruiting --> Recruiting
- | Keytruda (pembrolizumab) / Merck (MSD)
Phase classification: KEYMAKER-U03B: Substudy 03B: A Study of Immune and Targeted Combination Therapies in Participants With Second Line Plus (2L+) Renal Cell Carcinoma (MK-3475-03B) (clinicaltrials.gov) - Dec 19, 2023
P1/2, N=370, Active, not recruiting, Sponsor: Merck Sharp & Dohme LLC
Not yet recruiting --> Recruiting Phase classification: P1b/2 --> P1/2
- | Keytruda (pembrolizumab) / Merck (MSD), Lenvima (lenvatinib) / Eisai, Merck (MSD)
Trial completion date, Trial initiation date, Trial primary completion date: PULSAR: Pembrolizumab Plus Lenvatinib in Previously Treated Classic Kaposi Sarcoma (clinicaltrials.gov) - Dec 18, 2023
P2, N=25, Not yet recruiting, Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Phase classification: P1b/2 --> P1/2 Trial completion date: Mar 2029 --> Feb 2030 | Initiation date: Jun 2023 --> Feb 2024 | Trial primary completion date: Mar 2028 --> Feb 2029
- | Lenvima (lenvatinib) / Eisai, Merck (MSD)
Journal, Checkpoint inhibition, Checkpoint block: Near-Infrared-II Nanoparticles for Vascular Normalization Combined with Immune Checkpoint Blockade via Photodynamic Immunotherapy Inhibit Uveal Melanoma Growth and Metastasis. (Pubmed Central) - Dec 18, 2023
In this study, a novel nanoparticle denoted as Combo-NP is introduced, composed of a biodegradable NIR II fluorescent pseudo-conjugate polymer featuring disulfide bonds within its main chain, designated as TPA-BD, and the vascular inhibitor Lenvatinib...Furthermore, when combined with anti-programmed death-ligand 1 (PD-L1), they showcase notable inhibitory effects on tumor metastasis. The findings in this study introduce an innovative nanomedicine strategy aimed at triggering systemic anti-tumor immune responses for the treatment of Uveal melanoma.
- | Lenvima (lenvatinib) / Eisai, Merck (MSD)
Journal: Association between baseline blood pressure and the incidence of lenvatinib-induced hypertension in patients with thyroid cancer. (Pubmed Central) - Dec 17, 2023
Lenvatinib-induced hypertension appears the day after administration, and higher baseline blood pressure is a significant risk factor for developing hypertension grade??3. In cases of increased blood pressure with lenvatinib, early initiation of antihypertensives may prevent treatment interruption due to hypertension and maintain the therapeutic intensity of lenvatinib.
- | Lenvima (lenvatinib) / Eisai, Merck (MSD)
Journal: Well-controlled viremia reduces the progression of hepatocellular carcinoma in chronic viral hepatitis patients treated with lenvatinib. (Pubmed Central) - Dec 17, 2023
Before administration of lenvatinib, 57.1% of the HBV-HCC patients and 88.4% of the HCV-HCC patients had well-controlled viremia, and their PFS (8.8 vs. 3.1?months, p?<?0.001) and OS (30.2 vs. 12.8?months, p?=?0.041) were better than those who had uncontrolled viremia; moreover, well-controlled viremia reduced tumor progression in multivariate analysis (Hazard ratio: 0.41, 95% confidence interval: 0.25-0.68, p?=?0.001) after adjusting for albumin-bilirubin grade and concurrent treatment. HBV or HCV infection was not associated with tumor progression of HCC patients receiving lenvatinib, but viremia, controlled or not, was.
- || Loqtorzi (toripalimab) / Shanghai Junshi Biosci, Coherus Biosci, Lenvima (lenvatinib) / Eisai, Merck (MSD)
P2 data, Clinical Trial,Phase II, Journal: Lenvatinib, toripalimab plus FOLFOX chemotherapy in hepatocellular carcinoma patients with extrahepatic metastasis: A biomolecular exploratory, phase II trial (LTSC). (Pubmed Central) - Dec 17, 2023
FOLFOX chemotherapy in combination with lenvatinib and toripalimab showed promising antitumor activity with manageable toxicities in advanced HCC with extrahepatic metastasis. AKR1C2+ and CFHR4+ hepatocyte subtypes may be predictive biomarkers of resistance to the combination therapy.
- | Avastin (bevacizumab) / Roche, Lenvima (lenvatinib) / Eisai, Merck (MSD), Tecentriq (atezolizumab) / Roche
Retrospective data, Journal: Efficacy of Atezolizumab Plus Bevacizumab Versus Lenvatinib in Patients with Unresectable Hepatocellular Carcinoma: a Meta-analysis. (Pubmed Central) - Dec 14, 2023
Our study concluded that combination therapy with atezolizumab plus bevacizumab could increase the survival duration without affecting the disease course. Moreover, while the severity of adverse events was greater in the A?+?B group, their frequency was comparable to the lenvatinib group.
- Keytruda (pembrolizumab) / Merck (MSD), Lenvima (lenvatinib) / Eisai, Merck (MSD)
Network meta-analysis (NMA) to assess comparative efficacy of lenvatinib plus pembrolizumab compared with other first-line treatments for management of advanced renal cell carcinoma (aRCC). (Level 1, West Hall; Poster Bd # L1) - Dec 13, 2023 - Abstract #ASCOGU2024ASCO_GU_825;
Background: The CLEAR trial showed statistically significant improvements in overall survival (OS), progression-free survival (PFS), overall response rate (ORR), and complete response (CR) in subjects treated with lenvatinib plus pembrolizumab (L+P) vs. sunitinib...For PFS (assessed under United States Food and Drug Administration censoring rules), L+P showed a >75% probability of providing greater benefit over all available comparators, including numerical, but not statistically significant advantage over immunoncology (IO) therapies nivolumab+ipilimumab (N+I), avelumab+axitinib (A+A), nivolumab+cabozantinib (N+C) and pembrolizumab + axitinib (P+A). The benefit was significant for 13 out of 18 comparators
- Lenvima (lenvatinib) / Eisai, Merck (MSD)
Lenvatinib plus everolimus (LenEve) in patients with pre-treated advanced renal cell carcinoma (mRCC): Real world evidence (Relevance). (Level 1, West Hall; Poster Bd # H19) - Dec 13, 2023 - Abstract #ASCOGU2024ASCO_GU_780;
The benefit was significant for 13 out of 18 comparators High efficacy in second- and later-line in a heavily pre-treated real-world cohort of mRCC patients was demonstrated by LenEve, regardless of treatment line, IMDC risk group, initial dosing or previous treatment with immunotherapy.
- Keytruda (pembrolizumab) / Merck (MSD), Lenvima (lenvatinib) / Eisai, Merck (MSD), Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen
Outcomes of patients (pts) with advanced renal cell carcinoma (aRCC) treated with cabozantinib (CABO) after lenvatinib plus pembrolizumab (LEN+PEM). (Level 1, West Hall; Poster Bd # H15) - Dec 13, 2023 - Abstract #ASCOGU2024ASCO_GU_776;
P1b/2
In the CLEAR study, it produced a 71% objective response rate (ORR), an 18% complete response rate, and improved progression-free survival (PFS) and overall survival (OS) compared to sunitinib... In this cohort of heavily pretreated pts who received CABO after LEN+PEM, CABO demonstrated a modest clinical benefit in a minority of pts, underscoring the need to develop effective novel therapies for aRCC.
- Keytruda (pembrolizumab) / Merck (MSD), Lenvima (lenvatinib) / Eisai, Merck (MSD)
Pembrolizumab plus lenvatinib (P+L) versus alternate therapies in first-line (1L) for advanced renal cell carcinoma (aRCC): A network meta-analysis (NMA). (Level 1, West Hall; Poster Bd # H4) - Dec 13, 2023 - Abstract #ASCOGU2024ASCO_GU_765;
NMA indicates P+L has higher ORR and improved PFS compared to other regimens in 1L aRCC. No significant differences in OS were observed between P+L and competing interventions.
- Keytruda (pembrolizumab) / Merck (MSD), Lenvima (lenvatinib) / Eisai, Merck (MSD)
Pembrolizumab plus lenvatinib (P+L) versus alternative therapies in first-line (1L) advanced renal cell carcinoma (aRCC) by IMDC risk status: A network meta-analysis (NMA). (Level 1, West Hall; Poster Bd # H3) - Dec 13, 2023 - Abstract #ASCOGU2024ASCO_GU_764;
ORR analysis favored P+L over all alternative therapies in the network in intermediate+poor IMDC risk groups. No significant difference in OS was observed between P+L and other alternative therapies in the network.
- Fotivda (tivozanib) / Kyowa Kirin, Jazz, LG Chem
Efficacy, safety, and tolerability of tivozanib (TIVO) in heavily pretreated patients (pts) with advanced clear-cell renal cell carcinoma (ccRCC). (Level 1, West Hall; Poster Bd # G22) - Dec 13, 2023 - Abstract #ASCOGU2024ASCO_GU_762;
In this cohort of heavily pretreated pts with advanced ccRCC, TIVO yielded a modest clinical benefit in a minority of pts who received prior ICT, CABO, and LEN +/- EVE. TRAEs observed with TIVO were consistent with previously published reports.
- Health-related quality of life (HrQoL) of first-line treatments in metastatic renal cell carcinoma (mRCC): A network meta-analysis. (Level 1, West Hall; Poster Bd # G15) - Dec 13, 2023 - Abstract #ASCOGU2024ASCO_GU_755;
Global QoL was significantly improved with cabozantinib-nivolumab (CaboNivo) as compared to Nivo-ipilimumab (SMD 2.74, 95% CI 2.54; 2.93), lenvatinib-pembrolizumab (LenPem; 2.79, 2.53; 3.06), sunitinib (2.87, 2.72; 3.03), Pem-axitinib (PemAxi; 3.09, 2.89; 3.30) and atezolizumab-bevacizumab (AteBev; 3.24, 3.04; 3.45)... CaboNivo and NivoIpi as 1L therapy may offer an improved overall HrQoL compared to other contemporary treatment options in mRCC.
- Lenvima (lenvatinib) / Eisai, Merck (MSD), Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen
Real world data on treatment of chromophobe renal cell carcinoma. (Level 1, West Hall; Poster Bd # G12) - Dec 13, 2023 - Abstract #ASCOGU2024ASCO_GU_753;
No standardized treatment for metastatic disease could be identified. Overall treatment duration was comparable to clear cell carcinoma.
- Real world evidence comparison of first-line (1L) immune-oncology(IO)/tyrosine kinase inhibitor (TKI) vs. IO/IO combination therapy in renal cell carcinoma (RCC). (Level 1, West Hall; Poster Bd # G5) - Dec 13, 2023 - Abstract #ASCOGU2024ASCO_GU_746;
Limitations include the retrospective nature of the study, low power, lack of randomization, and potential unmeasured confounding factors (e.g., confounding by indication). Further investigation and prospective validation are needed to confirm these findings.* p<0.05.
- Pembrolizumab plus lenvatinib vs nivolumab plus cabozantinib in patients with metastatic renal cell carcinoma: A matching adjusted indirect comparison (MAIC). (Level 1, West Hall; Poster Bd # G2) - Dec 13, 2023 - Abstract #ASCOGU2024ASCO_GU_743;
Individual patient data in the intention to treat (ITT) population from KEYNOTE-581 (pem/len vs. sunitinib; 50.1 months median follow-up) were compared to published aggregated data in the same population from CheckMate-9ER (nivo/cabo vs. sunitinib; 44 months median follow-up)... In first-line metastatic RCC patients, the MAIC shows a statistically significant result in favor of Pembrolizumab plus Lenvatinib in PFS and ORR, and comparable CR and OS benefit.
- Treatment patterns and costs among patients with metastatic renal cell carcinoma (mRCC) in the United States: A real-world study using integrated claims and clinical data. (Level 1, West Hall; Poster Bd # F22) - Dec 13, 2023 - Abstract #ASCOGU2024ASCO_GU_742;
Although IO-IO was associated with higher treatment costs in the first 3 months, the subsequent monthly costs were lower vs IO+TKI. Results also indicated that retreatment with IO in the 2L setting is occurring in real-world practice.aHierarchically selected IMDC (calculated with lab data) before MSKCC (calculated) and CCQP (as reported by providers) risk scores.
- Preliminary analysis of baseline characteristics, patient reported outcomes (PROs), and treatment selection in ODYSSEY. (Level 1, West Hall; Poster Bd # F9) - Dec 13, 2023 - Abstract #ASCOGU2024ASCO_GU_729;
P
Reasons for selection of ST regimen differed among combination regimen classes. Completion of ODYSSEY will clarify baseline and longitudinal differences in pain and PROs among management strategies and give novel insights into the rationale for real world management of untreated pts with mRCC.
- Erectile function in patients with metastatic renal cell carcinoma treated with first-line therapy. (Level 1, West Hall; Poster Bd # F7) - Dec 13, 2023 - Abstract #ASCOGU2024ASCO_GU_727;
A prospective assessment in a large group of male mRCC patients revealed mild ED (17/25) in previously untreated patients and moderate ED (9/25) after four cycles/months of first-line therapy, especially in patients receiving TKIs. These changes did not correlate with kidney symptom index.
- Keytruda (pembrolizumab) / Merck (MSD), Lenvima (lenvatinib) / Eisai, Merck (MSD)
First-line pembrolizumab plus lenvatinib for non (Level 1, West Hall; Poster Bd # E1) - Dec 13, 2023 - Abstract #ASCOGU2024ASCO_GU_699;
P2
These results continue to support pembro + lenva as a first-line treatment option for pts with variant histologies of nccRCC. Clinical trial information: NCT04704219.
- Keytruda (pembrolizumab) / Merck (MSD), Lenvima (lenvatinib) / Eisai, Merck (MSD)
A multi-center, open-label phase II study of lenvatinib plus pembrolizumab (LEAP) in patients with renal cell carcinoma with brain metastasis previously treated with immune checkpoint blockade. (Level 1, West Hall; Poster Bd # M18) - Dec 13, 2023 - Abstract #ASCOGU2024ASCO_GU_694;
Exploratory analyses will include evaluation of tissue, blood-based and cerebrospinal fluid immune-related correlates, identification of imaging characteristics of treatment, evaluation of the neurological and cognitive function, seizure reduction, steroid, and opiate pain medication. Clinical trial information: N/A.
- Keytruda (pembrolizumab) / Merck (MSD), Lenvima (lenvatinib) / Eisai, Merck (MSD)
Pembrolizumab (pembro) plus lenvatinib (lenva) in patients (pts) with docetaxel-pretreated, metastatic castration-resistant prostate cancer (mCRPC): KEYNOTE-365 cohort E. (Level 1, West Hall; Poster Bd # F19) - Dec 13, 2023 - Abstract #ASCOGU2024ASCO_GU_334;
P1/2
Safety was generally consistent with the individual profiles and for the combination of these agents. Clinical trial information: NCT02861573.
- Keytruda (pembrolizumab) / Merck (MSD), Lenvima (lenvatinib) / Eisai, Merck (MSD), Sutent (sunitinib) / Pfizer
Subgroup analyses of efficacy outcomes by baseline tumor size in the phase 3, open-label CLEAR trial. (Level 3, Ballroom) - Dec 13, 2023 - Abstract #ASCOGU2024ASCO_GU_162;
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-na
- | Lenvima (lenvatinib) / Eisai, Merck (MSD)
Phase classification: KEYNOTE 524: A Trial of Lenvatinib Plus Pembrolizumab in Participants With Hepatocellular Carcinoma (clinicaltrials.gov) - Dec 12, 2023
P1, N=104, Completed, Sponsor: Eisai Co., Ltd.
1069 treatment-na Phase classification: P1b --> P1