Nivolumab

BMS Reports Five-Year Data of Opdivo (nivolumab) + Yervoy (ipilimumab) in P-III CheckMate -214 for the Treatment of Advanced or Metastatic Renal Cell Carcinoma

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 …

BMS Reports Five-Year Data of Opdivo (nivolumab) + Yervoy (ipilimumab) in P-III CheckMate -214 for the Treatment of Advanced or Metastatic Renal Cell Carcinoma Read More »

ONO and BMS Report Submission of sBLA for Opdivo (nivolumab) + Yervoy (ipilimumab) as 1L Treatment of Unresectable Advanced or Recurrent ESCC in Japan

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 …

ONO and BMS Report Submission of sBLA for Opdivo (nivolumab) + Yervoy (ipilimumab) as 1L Treatment of Unresectable Advanced or Recurrent ESCC in Japan Read More »

BMS Reports Three-Year Data of Opdivo (nivolumab) + Yervoy (ipilimumab) in P-III CheckMate -743 Trial for 1L Treatment of Unresectable Malignant Pleural Mesothelioma

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 …

BMS Reports Three-Year Data of Opdivo (nivolumab) + Yervoy (ipilimumab) in P-III CheckMate -743 Trial for 1L Treatment of Unresectable Malignant Pleural Mesothelioma Read More »

BMS Reports EMA’s Validation of MAA for Opdivo (nivolumab) + Yervoy (ipilimumab) and Opdivo + CT to Treat Esophageal Squamous Cell Carcinoma

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 …

BMS Reports EMA’s Validation of MAA for Opdivo (nivolumab) + Yervoy (ipilimumab) and Opdivo + CT to Treat Esophageal Squamous Cell Carcinoma Read More »

BMS Presents Results of Opdivo (nivolumab) + CT or Yervoy (ipilimumab) in P-III CheckMate -648 Trial for Unresectable Advanced or Metastatic ESCC at ASCO 2021

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. & …

BMS Presents Results of Opdivo (nivolumab) + CT or Yervoy (ipilimumab) in P-III CheckMate -648 Trial for Unresectable Advanced or Metastatic ESCC at ASCO 2021 Read More »

BMS Receive the CHMP’s Positive Opinion Recommending Approval of Opdivo (nivolumab) + Yervoy (ipilimumab) for dMMR or MSI-H mCRC After Prior Chemotherapy

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 …

BMS Receive the CHMP’s Positive Opinion Recommending Approval of Opdivo (nivolumab) + Yervoy (ipilimumab) for dMMR or MSI-H mCRC After Prior Chemotherapy Read More »

ViewPoints Interview: Ipsen’s Dr. Med. Steven Hildemann Shares Insight on the EC’s Approval of Cabometyx + Nivolumab for Advanced Renal Cell Carcinoma

In an interview with PharmaShots, Prof. Dr. Med. Steven Hildemann, Executive Vice President, Chief Medical Officer, Head of Global Medical Affairs, and Patient Safety of Ipsen share his views on the approval of the combination regimen for aRCC. He also shed light on the company’s near-term goals in the coming years. Shots: The EC approval …

ViewPoints Interview: Ipsen’s Dr. Med. Steven Hildemann Shares Insight on the EC’s Approval of Cabometyx + Nivolumab for Advanced Renal Cell Carcinoma Read More »

BMS Reports the US FDA’s Acceptance of Opdivo’s sBLA for Priority Review to Treat Muscle Invasive Urothelial Carcinoma

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 …

BMS Reports the US FDA’s Acceptance of Opdivo’s sBLA for Priority Review to Treat Muscle Invasive Urothelial Carcinoma Read More »

BMS’ Opdivo (nivolumab) + Cabometyx (cabozantinib) Receive CHMP’s Positive Opinion as 1L Treatment for Advanced Renal Cell Carcinoma

Shots: The CHMP recommendation is based on P-III CheckMate -9ER trial involves assessing Opdivo + Cabometyx vs sunitinib in 651 patients with previously untreated advanced or metastatic RCC The P-III result showed improvements in PFS, OS and ORR with consistent efficacy benefits observed across key subgroups of patients and was well tolerated, with a low …

BMS’ Opdivo (nivolumab) + Cabometyx (cabozantinib) Receive CHMP’s Positive Opinion as 1L Treatment for Advanced Renal Cell Carcinoma Read More »

BMS’ Opdivo (nivolumab) Receives EC’s Approval as 2L Treatment for Unresectable Advanced and Metastatic Esophageal Squamous Cell Carcinoma

Shots: The approval is based on P-lll ATTRACTION-3 study involve the assessment of Opdivo vs CT (docetaxel or paclitaxel) for patients with esophageal cancer refractory/ intolerant to 1L combination therapy with fluoropyrimidine- and Pt.-based drugs Results: reduction in risk of death (23%); m-OS (10.9 vs 8.4 mos.); @12 & 18-mos. OS rates (47% & 31% …

BMS’ Opdivo (nivolumab) Receives EC’s Approval as 2L Treatment for Unresectable Advanced and Metastatic Esophageal Squamous Cell Carcinoma Read More »

BMS Report Results of Opdivo (nivolumab) + CT in P-III CheckMate-816 Trial for Resectable Non-Small Cell Lung Cancer

Shots: The P-III CheckMate-816 study involves assessing of Opdivo (360mg) + CT (q3w for 3 doses) vs CT (q3w for 3 doses), followed by surgery as a neoadjuvant treatment in 358 patients with resectable NSCLC The study met its 1EPs of improved pathologic complete response. The positive results marks the first time an immune checkpoint …

BMS Report Results of Opdivo (nivolumab) + CT in P-III CheckMate-816 Trial for Resectable Non-Small Cell Lung Cancer Read More »

BMS’ Opdivo (nivolumab) + Yervoy (ipilimumab) + CT Receive Health Canada Approval for Metastatic Non-Small Cell Lung Cancer

Shots: The approval is based on P-III CheckMate -9LA study assessing Opdivo + Yervoy combined with two cycles of platinum-doublet CT vs CT (four cycles followed by optional pemetrexed maintenance therapy if eligible) as a 1L treatment in patients with metastatic/ recurrent NSCLC regardless of PD-L1 expression and histology The study met its 1EPs & …

BMS’ Opdivo (nivolumab) + Yervoy (ipilimumab) + CT Receive Health Canada Approval for Metastatic Non-Small Cell Lung Cancer Read More »