Shots: The P-III IMpassion131 study involves assessing of Tecentriq + paclitaxel vs PBO + paclitaxel, in 651 people in a ratio (2:1) with previously untreated, inoperable, LA/ m-TNBC The study did not meet its 1EPs of PFS for 1L treatment of people with m-TNBC) in the PD-L1+ population. The data for 2EPs of OS showed […]Read More
Shots: The sBLA submission is based on P-III IMpower110 study assessing Tecentriq as monothx. vs CT in 572 PD-L1-selected (TC3/IC3-WT), CT-naïve patients with advanced sq. or non-sq. NSCLC without ALK or EGFR mutations The P-III Impower110 study results: improvement in OS by 7.1mos. (20.2 vs 13.1mos.), the safety profile is consistent with its known safety […]Read More
Shots: The NMPA’s approval is based on P-III IMpower133 study assessing Tecentriq + CT vs PBO + CT as monothx. in 403 CT naïve patients in a ratio (1:1) with ES-SCLC The P-III IMpower study results: OS (12.3 vs 10.3 mos.); mPFS (5.2 vs 4.3 mos.); follow up analysis @18mos. OS rate (34% vs 21%); […]Read More
Shots: The P-III IMbrave150 study involves assessing Tecentriq (IV, 1200mg) + Avastin (IV, 15mg/kg) vs Sorafenib (400mg, bid) in 501 (194 from China) patients in a ratio (2:1) in patients with unresectable HCC, prior not treated with systemic therapy The Chinese patients demonstrated a 56% improvement in OS, 40% reduction in PFS and is well […]Read More
Shots: The sBLA is based on P-III IMbrave150 study involve assessing of Tecentriq (1200mg, IV) + Avastin (IV, 15 mg/kg) vs Sorafenib (PO, 400mg, bid) in 501 patients in a ratio 2:1 with unresectable HCC prior not treated with systemic therapies The P-III IMbrave150 study results: 42% reduction in risk of death; 41% reduction in […]Read More
Shots: The P-III IMvigor010 study involves assessing Tecentriq as an adjuvant monothx. compared to observation in 809 patients with MIUC who are at high risk for recurrence following resection The P-III IMvigor010 study results: did not meet its 1EPs of DFS; safety profile is consistent with the previous profiles as no new signals were identified […]Read More
Shots: The P-III IMbrave150 study involve assessing of Tecentriq (1200mg, IV) + Avastin (IV, 15 mg/kg) vs Sorafenib (PO, 400mg, bid) in 501 patients in a ratio 2:1 with unresectable HCC prior not treated with systemic therapies The P-III IMbrave 150 study results: 42% reduction in risk of death, 41% reduction in risk of disease […]Read More
Shots: The P-III IMbrave150 study involve assessing of Tecentriq (1200 mg on day 1 of each 21-day cycle) in combination with Avastin (15 mg/kg on day 1 of each 21-day cycle) vs SoC sorafenib in 501 patients in a ratio (2:1) with unresectable HCC with no prior treatment with systemic therapy The P-III III IMbrave150 […]Read More
Shots: involves assessing of Tecentriq + CT vs CT as monothx. in 1,213 patients with previously untreated LA or metastatic urothelial carcinoma (mUC) eligible and ineligible for cisplatin chemotherapy The P-III IMvigor130 study results: mPFS (8.2 vs 6.3mos.); median OS (16.0 vs 13.4 mos.); ORR (47.4% vs 43.8%); safety data of combination therapy is consistent […]Read More
Shots: The approval is based on P-III IMpassion130 study assessing Tecentriq + nab-paclitaxel vs PBO + nab-paclitaxel in 902 patients in ratio (1:1) with unresectable locally advanced or metastatic TNBC treated with no prior CT for disease P-III IMpassion130 study results: reduction the risk of disease worsening or death by 38%; mPFS (7.5 mos. vs […]Read More
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