In an interview with PharmaShots, Dr. Ian Waxman, MD, Development Lead, Gastrointestinal Cancer at BMS shared his views on the EC’s approval of Opdivo (nivolumab) + Yervoy (ipilimumab) for the Treatment of dMMR or MSI-H mCRC Shots: The approval is based on P-II CheckMate -142 study evaluating Opdivo + Yervoy in patients with dMMR or […]Read More
Shots: The P-III CheckMate -214 trial evaluates Opdivo (3mg/kg) + Yervoy (1mg/kg, q3w for 4 doses) vs sunitinib in 1096 patients with previously untreated advanced/mRCC Results: @median follow-up of 67.7mos., combination showed superior OS in intermediate, poor risk patients & randomized or ITT population; m-OS (47.0 vs 26.6mos.) & (55.7 vs 38.4mos.); ORR (42% vs […]Read More
Shots: The application is based on P-III CheckMate -648 study evaluating Opdivo (3mg/kg, q2w, IV) + Yervoy (1mg/kg, q6w up to 24mos.) or Opdivo + CT vs CT alone in patients with unresectable advanced or recurrent ESCC The results demonstrated an improvement in OS at pre-specified interim analysis in patients with tumor cell PD-L1 expression […]Read More
Shots: The P-III CheckMate -743 trial evaluates Opdivo (3mg/kg, q2w) + Yervoy (1mg/kg, q6w) vs CT in 605 patients with previously untreated unresectable MPM. The results will be presented at ESMO 2021 The result showed an improvement in OS with a reduction in risk of death, patients were alive (23% vs 15%) @3yrs., improvement in […]Read More
Shots: The applications are based on P-III CheckMate -648 trial evaluates Opdivo (3 mg/kg, q2w) + Yervoy (1 mg/kg, q6w up to 24mos.) or Opdivo (nivolumab) + CT vs CT alone in patients with unresectable advanced or metastatic ESCC Results: Both combinations showed OS benefit over CT at the pre-specified interim analysis in patients with […]Read More
Shots: The companies will initiate P-I/II study evaluating the safety and preliminary efficacy of BBP-398 in combination with both Opdivo as dual therapy & Opdivo + KRASG12C inhibitor as triplet therapy in NSCLC patients with KRAS mutations, as 1L & 2L treatment options BridgeBio will sponsor the study while BMS will provide nivolumab to the […]Read More
Shots: The P-III CheckMate -648 trial evaluating Opdivo + CT or Opdivo (3 mg/kg, q2w) + Yervoy (1 mg/kg, q6w up to 24mos.) in patients with unresectable advanced or metastatic ESCC Results: Both combinations showed OS benefits over CT in PD-L1 positive & all-randomized populations, m-OS for Opdivo + CT (13.7 vs 9.1 mos. & […]Read More
Shots: The approval is based on P-III CheckMate -743 study assessing Opdivo + Yervoy vs SOC Pt. based CT in patients with previously untreated unresectable malignant pleural mesothelioma The combination regimen has demonstrated significant extension of OS vs CT. The safety profile of combination treatment was consistent with those previously reported in the studies for […]Read More
Shots: The opinion is based on P-II CheckMate -142 study assessing Opdivo + Yervoy in patients with mismatch repair deficient or microsatellite instability–high metastatic colorectal cancer whose disease had progressed during or after prior treatment with CT If approved, Opdivo in combination with Yervoy will be the first dual immunotherapy approved in the EU in […]Read More
Shots: The filing is based on results from the P-III CheckMate -274 trial evaluating Opdivo (240mg, q2w for up to 1 yrs.) vs PBO in a ratio (1:1) in 709 patients with muscle-invasive urothelial cancer who are at a high risk of recurrence after radical surgery The study demonstrated the improvement in DFS regardless of […]Read More
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