Results showed that the combination of pembrolizumab and axitinib met both primary endpoints of overall survival and progression-free survival. The combination therapy of pembrolizumab plus axitinib is superior to sunitinib monotherapy with respect to Overall Survival (OS). Background: Axitinib plus pembrolizumab showed superior overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) versus sunitinib in a randomised phase III trial in patients with advanced renal-cell carcinoma (RCC). Combination lenvatinib plus pembrolizumab offered significantly improved progression-free survival (PFS) and overall survival (OS) over sunitinib and represents a new … Background: Nivolumab in combination with cabozantinib (N+C) has demonstrated significantly improved progression-free survival (PFS), objective response rate … The 1- and 2-year OS rates were 90% and 74% with pembrolizumab/axitinib and were 79% and 66% with sunitinib, respectively. As of April 2020, preferred first-line treatment options for mRCC are pembrolizumab + axitinib and ipilimumab + nivolumab, based on the improvement in overall survival and progression-free … Trial design KEYNOTE-426 enrolled patients with clear cell metastatic RCC and Karnofsky performance status score ≥70%. The trial … The analysis of overall survival found pembrolizumab plus axitinib (HR, 0.53) and nivolumab plus ipilimumab (HR, 0.63) improved survival. Combo reduced disease progression, offered durable survival benefit in patients with advanced disease Pembrolizumab plus axitinib is superior to sunitinib for the treatment of … • In the absence of head-to … Pembrolizumab having a 38% overall response rate (ORR) with an 8.7-month progression-free survival (PFS) rate in a Phase 2 trial Axitinib having a 32% ORR and a 10.1 month PFS in a Phase … No significant differences in overall response rate, progression free survival, or overall survival were observed between nivolumab-ipilimumab and pembrolizumab-axitinib … 3.3 The clinical evidence came from KEYNOTE‑426, an open-label, randomised phase 3 trial that compared pembrolizumab plus axitinib with sunitinib (median follow up of 12.8 months). In the KEYNOTE-426 trial, pembrolizumab plus axitinib significantly extended overall sur- vival (OS) and progression-free survival in cases of advanced renal cell carcinoma. Achievement of an overall survival benefit with combinations . The median overall survival had not yet been reached at the time of analysis, and a respective 87.1% and 69.4% of patients were alive at the two timepoints. KEYTRUDA ® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with Inlyta ® (axitinib), Pfizer’s tyrosine kinase inhibitor, met both primary endpoints of overall survival (OS) and progression-free survival (PFS) in the first-line treatment of advanced or metastatic renal cell carcinoma (RCC), the most common type of kidney cancer. As of April 2020, preferred first-line treatment options for mRCC are pembrolizumab + axitinib and ipilimumab + nivolumab, based on the improvement in overall survival and progression-free survival compared to sunitinib, as observed in … First-line therapy with pembrolizumab plus axitinib significantly improved overall survival (OS), progression-free survival (PFS), and objective response rates compared with standard-of-care sunitinib in patients with clear cell metastatic renal cell carcinoma (RCC) in KEYNOTE-426. Has histologically … Overall, the committee considered that the … Updated overall survival analysis shows that 74% of patients are alive from the pembro/axi arm at 24 months, compared with 66% of patients on sunitinib arm. improvements in overall survival (OS), progression-free survival (PFS) and overall response rate (ORR) in ccmRCC subjects treated with P+A versus (vs) sunitinib. In the U.S., the overall five-year survival rate for patients diagnosed with lung cancer is 24%, a 14% improvement over the last five years. CONCLUSIONS: Among patients with previously untreated advanced renal-cell carcinoma, treatment with pembrolizumab plus axitinib resulted in significantly longer overall survival and … Kaplan-Meier estimates showed similar overall survival rates in the pembrolizumab plus axitinib group in patients with confirmed complete response per RECIST version 1.1 and those in the −100% to −80% tumour size reduction category (appendix p 15). Active Comparator: axitinib alone (control) Axitinib will be administrated orally 5 mg twice a day, with a … SMC restriction: treatment with pembrolizumab is subject to a two-year clinical stopping rule. Pembrolizumab (Keytruda) has received approval from the FDA in combination with axitinib (Inlyta) for the frontline treatment of patients with advanced renal cell carcinoma (RCC), … Results. ... KEYTRUDA With Axitinib. The 12-month overall survival rate was 89.9 percent in the combination group versus 78.3 percent in … The benefits of pembrolizumab plus axitinib with respect to overall survival and progression-free survival were observed in all subgroups examined, including … In terms of progression-free survival, median PFS in the pembro/axi arm was 15.4 months and 11.1 months with sunitinib, HR 0.71. The objective response held at 60.2% with pembro/axi and was 40% in the sunitinib arm. The median duration of response on pembro/axi was 23.5 months compared with 15.9 months with sunitinib. The results recently published inferred that the combinations of immune agents (i.e., nivolumab plus ipilimumab) or immune-checkpoint inhibitors with antivascular agents (i.e., … toxicity. Worldwide, approximately 400,000 new cases of kidney cancer occurred in 2018, with 175,000 deaths associated with this disease. The overall response rate was 60% of the 432 patients treated with pembrolizumab plus axitinib compared with 40% of the 429 patients given sunitinib (P < … Patients received pembrolizumab, nivolumab, avelumab, or nivolumab–ipilimumab, with concurrent use of sunitinib, axitinib, pazopanib, lenvatinib, or cabozantinib. A partitioned survival model with three states (progression-free, progressed, death) evaluated lifetime costs and quality-adjusted life-years (QALYs) for pembrolizumab/axitinib and other first-line regimens: sunitinib, pazopanib and avelumab/axitinib in the overall population; and sunitinib, cabozantinib and nivolumab/ipilimumab in the subgroup with intermediate/poor … When antiangiogenic VEGFR monotherapy was the standard of care, the 5-year survival rate for patients with advanced RCC was 12%.13,14The extent to which nivolumab-ipilimumab and pembrolizumab-axitinib will improve outcomes remains to be determined. As reported in The Lancet Oncology by Thomas Powles, MD, of Barts Cancer Institute, London, and colleagues, extended follow-up of the phase III KEYNOTE-426 trial shows continued … Among patients with untreated metastatic renal cell carcinoma (RCC) from Eastern Asia, first line treatment with pembrolizumab plus axitinib provided prolonged overall survival … Abstract Background: In the randomized, open-label, phase III KEYNOTE-426 study (NCT02853331), pembrolizumab + axitinib significantly improved overall survival (OS), … Twenty-six participants in total will be enrolled into the study. In the U.S., the overall five-year survival rate for patients diagnosed with lung cancer is 24%, a 14% improvement over the last five years. As frontline therapy, pembrolizumab plus axitinib led to a statistically significant survival benefit over standard-of-care therapy, according to data presented at … The efficacy of nivolumab–axitinib was comparable to that of available approved ICI–TKI combinations in this setting, said Zibelman, adding that the safety profile was also similar. METHODS. At a median follow-up of 30.6 months, the median overall survival (OS) had not yet been reached with pembrolizumab/axitinib compared with 35.7 months with sunitinib monotherapy (HR, 0.68; P = .0003). Patients in the pembrolizumab-axitinib group with an “at least 80% reduction in target lesions within 6 months of randomization had a durable subsequent overall survival … Introduction. The main efficacy measures were overall survival (OS) and progression-free survival (PFS), assessed by blinded independent central review (RECIST 1.1.) A second interim analysis of the phase 3 KEYNOTE-426 study (NCT02853331) indicated that the combination of pembrolizumab (Keytruda) and axitinib (Inlyta) resulted in benefit to adjusted overall survival (OS) and type and timing of subsequent therapy versus sunitinib (Sutent) in patients with clear cell renal cell carcinoma (ccRCC), according to data … Axitinib plus pembrolizumab showed superior overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) versus sunitinib in a … Overall Survival [ Time Frame: 2 year ] To determine overall survival (OS) from pembrolizumab initiation ... History of allergic reactions attributed to compounds of similar chemical or biologic composition to pembrolizumab or axitinib. In the U.S., the overall five-year survival rate for patients diagnosed with lung cancer is 24%, a 14% improvement over the last five years. At a median follow-up of 12.8 months, patients who received the combination therapy had a 47 percent reduction in the risk of death as compared with sunitinib. The exploratory analysis model was most sensitive to overall survival rates (incremental cost-effectiveness ratio at lower limit of pembrolizumab-axitinib rate and upper … Overall confirmed response rate (ORR) was a key secondary endpoint. In clinical trials, pembrolizumab plus axitinib and nivolumab plus ipilimumab demonstrated to improve overall survival (OS) when compared to sunitinib for mRCC patients … Results from the randomized, phase III KEYNOTE-426 clinical trial show that first-line therapy with a combination of the PD-1 targeted immunotherapy pembrolizumab and the VEGF-targeted tyrosine kinase inhibitor, axitinib extended both overall survival and progression-free survival for patients with clear-cell metastatic renal cell carcinoma (mRCC), compared with the … Among patients with untreated metastatic renal cell carcinoma (RCC) from Eastern Asia, first line treatment with pembrolizumab plus axitinib provided prolonged overall survival (OS) and progression-free survival (PFS), as well as a higher objective response rate (ORR), than treatment with sunitinib. A partitioned survival model with three states (progression-free, progressed, death) evaluated lifetime costs and quality-adjusted life-years (QALYs) for pembrolizumab/axitinib … With a median follow-up of 30.6 months, KEYNOTE-426 demonstrated that pembrolizumab and axitinib (n=432) had a significant benefit compared with sunitinib (n=429) … The median overall survival had not yet been reached at the time of analysis, and a respective 87.1% and 69.4% of patients were alive at the two timepoints. Rini BI, Plimack ER, Stus V, et al. 2 For patients with localized disease, the 5-year relative survival rate is 93%, which drops to 13% for … 1,2 Our Real-world outcomes of front-line axitinib plus pembrolizumab versus ipilimumab plus nivolumab for metastatic clear cell renal cell carcinoma: Landmark 18-month survival analysis Kevin … Improving survival rates are due in part to earlier detection and screening, reduction in smoking, advances in diagnostic and surgical procedures as well as the introduction of new therapies. Median survival is not yet reached with pembro/axi and was 35.7 months with sunitinib. This is a Phase 2, open label study of pembrolizumab in combination with axitinib in adult women with recurrent endometrial cancer with deficient mismatch repair system. It is possible that by combining pembrolizumab with axitinib, the predictive value of PD-L1 is being masked,” said Dr. Powles. 1 Around 85% of kidney cancers are renal cell carcinoma (RCC), of which 70% have a clear cell histology (ccRCC). The long-term follow-up results from a phase I clinical trial of axitinib plus pembrolizumab in patients with advanced renal cell carcinoma are reported. ALEXANDRIA, Va. – Results from the randomized, phase III KEYNOTE-426 clinical trial show that first-line therapy with a combination of the PD-1 targeted immunotherapy pembrolizumab (Keytruda) and the VEGF-targeted tyrosine kinase inhibitor axitinib (Inlyta) extended both overall survival and progression-free survival for patients with clear-cell … Previous results from KEYNOTE-426, a phase III randomized, open-label trial … Total exposure of pembrolizumab plus axitinib was 7715·4 person-months and total exposure of sunitinib was 6036·4 person-months. Treatment-related adverse events of any grade occurred in 413 (96%) of 429 patients in the pembrolizumab plus axitinib group and in 415 (98%) of 425 patients in the sunitinib group ( table 3 ). Five-year overall survival for patients with advanced non-small-cell lung cancer treated with pembrolizumab: results from the phase I KEYNOTE-001 study. 16. (axitinib) tablets for oral administration (prescribing information). 17. SUTENT 12·5 mg, 25 mg, 37·5 mg, and 50 mg hard capsules (summary of product characteristics), Kent. 18. with pembrolizumab plus axitinib resulted in significantly longer overall survival and progression-free survival, as well as a higher objective response rate, … Improving survival rates are due in part to earlier detection and screening, reduction in smoking, advances in diagnostic and surgical procedures as well as the introduction of new therapies. Improving survival rates are due in … We report long-term efficacy and safety of the axitinib/pembrolizumab from the phase I trial (NCT02133742), after 46-55 months from … 2019;380:1116-1127. Results from that study showed that combining pembrolizumab and axitinib had significant clinical benefits for patients, including long overall survival. Among patients with untreated metastatic renal cell carcinoma (RCC) from Eastern Asia, first line treatment with pembrolizumab plus axitinib provided prolonged overall survival (OS) and progression-free survival (PFS), as well as a higher objective response rate (ORR), than treatment with sunitinib. Kaplan-Meier estimates showed similar overall survival rates in the pembrolizumab plus axitinib group in patients with confirmed complete response per RECIST … KEYTRUDA® (pembrolizumab) in Combination with Inlyta® (axitinib) as First-Line Treatment for Patients with Advanced Renal Cell Carcinoma (RCC) 9/4/2019 European Approval Based on … Pembrolizumab/axitinib significantly prolonged overall survival (OS) and progression-free survival (PFS), and increased objective response rate versus sunitinib in the phase III trial KEYNOTE-426 among previously untreated patients with advanced renal cell carcinoma (RCC). These data continue As of April 2020, preferred first-line treatment options for mRCC are pembrolizumab + axitinib and ipilimumab + nivolumab, based on the improvement in overall … INLYTA® (axitinib) in combination with pembrolizumab is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC). All participants enrolled will receive pembrolizumab as standard of care combined with axitinib. INLYTA as a single agent is indicated for the … Outcomes including objective response rate (ORR), progression-free survival (PFS), and toxicity were analyzed via descriptive statistics and the Kaplan–Meier method. In this study, 861 patients with advanced or metastatic RCC were randomly assigned to first-line treatment with pembrolizumab plus axitinib for up to 24 months, or monotherapy with sunitinib. significant difference in progression-free survival or overall survival for the indirect comparison of pembrolizumab plus axitinib with cabozantinib. Following 1:1 randomization, patients were treated … Treatment with pembrolizumab and axitinib appears to offer durable anti-tumour response at long-term follow up with an objective response rate of 85%, progression-free survival and overall survival rates of 94.7% and 74.8% at 36 months respectively . Median overall survival was not reached at a minimum follow-up of 17.6 months. Pembrolizumab plus axitinib versus sunitinib for advanced renal-cell carcinoma. of VEGF or VEGFR inhibitor-targeted therapy and immunotherapy has been inconsistent across different regimens in advanced renal … Objective: Pembrolizumab/axitinib significantly prolonged overall survival (OS) and progression-free survival (PFS), and increased objective response rate versus sunitinib in the phase III trial KEYNOTE-426 among previously untreated patients with … As first-line therapy for locally advanced or metastatic renal cell carcinoma, pembrolizumab plus axitinib offers longer overall and progression-free survival compared … Updated data from the KEYNOTE-426 trial was presented at the ASCO 2020 Virtual Annual Meeting. 4578. Patients in the pembrolizumab-axitinib group with an “at least 80% reduction in target lesions within 6 months of randomization had a durable subsequent overall survival benefit (i.e., 36 months survival), similar to patients who had RECIST-defined complete response,” Dr. Powles and colleagues wrote. of VEGF or VEGFR inhibitor-targeted therapy and immunotherapy has been inconsistent across different regimens in advanced renal cancer. Results from that study showed that combining pembrolizumab and axitinib had significant clinical benefits for patients, including long overall survival. METHODS. overall survival and progression-free survival in the intention-to-treat population. 1 Kaplan-Meier estimates showed similar overall survival rates in the pembrolizumab plus axitinib group in patients with confirmed complete response per RECIST version 1.1 and those in the −100% to −80% tumour size reduction category (appendix p 15). Improving survival rates are due in … Overall Survival [ Time Frame: 2 year ] To determine overall survival (OS) from pembrolizumab initiation ... History of allergic reactions attributed to compounds of similar … Background. Pembrolizumab intravenously over 30 min minutes at 200 mg every 3 weeks. Indeed, the combination of pembrolizumab plus axitinib was consistently found to be associated with equal or better overall survival than that achieved with sunitinib regardless … Eligibility Criteria. In an open-label, phase III study, first-line treatment with pembrolizumab plus axitinib significantly … After a median follow-up of 12.8 months, pembrolizumab plus axitinib resulted in better overall survival (HR 0.53, P<0.0001), median progression free survival (15.1 months in the combination arm versus 11.1 months in the sunitinib arm, HR 0.69, P<0.001) and Achievement of an overall survival benefit with combinations . The efficacy of … “Overall, we have not previously seen a renal cancer study which has improved response, progression-free survival, and overall survival. At the time of data cutoff, 193 patients given pembrolizumab plus axitinib and 225 patients given sunitinib had died, yielding a median overall survival of 45.7 months for the … In the U.S., the overall five-year survival rate for patients diagnosed with lung cancer is 24%, a 14% improvement over the last five years. Plimack said the study … Background. First-line treatment with pembrolizumab plus axitinib significantly improved overall survival (OS) and progression-free survival (PFS) in patients with advanced clear-cell RCC* who had … The overall … Merck’s KEYTRUDA® (pembrolizumab) in Combination with Pfizer’s Inlyta® (axitinib) Significantly Improved Overall Survival (OS) and Progression-free Survival (PFS) as … Primary endpoints were overall survival (OS) and progression-free survival (PFS). Pembrolizumab (Keytruda ® … However, with extended follow-up, pembrolizumab plus axitinib continued to show a survival benefit compared with sunitinib. Axitinib plus pembrolizumab showed superior overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) versus sunitinib in a randomised phase III trial in patients with advanced renal-cell carcinoma (RCC). In Phase 3 KEYNOTE-394 Study, KEYTRUDA Showed Statistically Significant Improvement in OS Versus Placebo Merck (NYSE: MRK), known as MSD outside the United … CONCLUSIONS: Among patients with previously untreated advanced renal-cell carcinoma, treatment with pembrolizumab plus axitinib resulted in significantly longer overall survival and progression-free survival, as well as a higher objective response rate, than treatment with sunitinib. After a median follow-up of 30.6 months, the authors observed a continued clinical benefit for patients treated with pembrolizumab plus axitinib over sunitinib in regard to overall … The median progression-free survival was 20.9 months (95% CI, 15.4 to not evaluable). The primary outcome measures in KEYNOTE‑426 were overall survival (hazard ratio 0.53; 95% confidence interval 0.38 to 0.74, p=0.00005) and progression-free survival (hazard … N Engl J Med. First-line therapy with a combination of pembrolizumab (Keytruda, Merck) and axitinib (Inlyta, Pfizer) extended both overall survival (OS) and progression-free survival in patients with clear-cell metastatic renal cell carcinoma … In the U.S., the overall five-year survival rate for patients diagnosed with lung cancer is 24%, a 14% improvement over the last five years. Inclusion Criteria. The frontline combination of pembrolizumab (Keytruda) plus axitinib (Inlyta) continued to show a survival benefit over single-agent sunitinib (Sutent) in patients with renal cell carcinoma (RCC), according to 3.5-year follow-up data from the phase 3 KEYNOTE-426 trial presented at the 2021 ASCO Annual Meeting. This is, therefore, a major step forward in renal cancer.” Plimack said the study … In Phase 3 KEYNOTE-394 Study, KEYTRUDA Showed Statistically Significant Improvement in OS Versus Placebo Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Phase 3 KEYNOTE-394 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in Asian patients with advanced hepatocellular carcinoma (HCC) …
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