1L

AstraZeneca Reports Results of Imfinzi + Tremelimumab in P-III HIMALAYA Study for 1L Treatment of Unresectable Liver Cancer

Shots: The P-III HIMALAYA study Imfinzi monothx. and the STRIDE regimen (single priming dose of tremelimumab 300mg + Imfinzi 1500mg followed by Imfinzi q4w vs sorafenib in ~1,324 patients with unresectable, advanced HCC who had not been treated with prior systemic therapy and were not eligible for locoregional therapy The combination regimen demonstrated a favorable …

AstraZeneca Reports Results of Imfinzi + Tremelimumab in P-III HIMALAYA Study for 1L Treatment of Unresectable Liver Cancer Read More »

ONO and BMS’ Opdivo + Yervoy Receive Approval for 1L Treatment for Unresectable Advanced or Recurrent Malignant Pleural Mesothelioma

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 …

ONO and BMS’ Opdivo + Yervoy Receive Approval for 1L Treatment for Unresectable Advanced or Recurrent Malignant Pleural Mesothelioma Read More »

Eli Lilly and Innovent Report the US FDA’s Acceptance of Sintilimab + Chemotherapy for 1L Treatment for Non-Squamous NSCLC

Shots: The submission is based on a P-III ORIENT-11 study assessing sintilimab (200mg) + pemetrexed and platinum CT vs PBO + CT as a 1L treatment for 397 patients in a ratio (2:1) with advanced or metastatic nonsq. NSCLC, with no sensitizing EGFR mutations or ALK rearrangements The anticipated PDUFA date for this application is …

Eli Lilly and Innovent Report the US FDA’s Acceptance of Sintilimab + Chemotherapy for 1L Treatment for Non-Squamous NSCLC Read More »

BMS’ Opdivo (nivolumab) + Cabometyx (cabozantinib) Receive EC’s Approval for 1L Treatment of Advanced Renal Cell Carcinoma

Shots: The approval is based on P-III CheckMate -9ER trial involves assessing Opdivo + Cabometyx vs sunitinib in 651 patients with previously untreated advanced or metastatic RCC Results: @median follow-up of 10.6 mos.; m-PFS (16.6 vs 8.3mos.), ORR (55.7% vs 27.1%); CR (9.3% vs 4.3%); OS (40% reduction in risk of death), Grade 3+ AEs …

BMS’ Opdivo (nivolumab) + Cabometyx (cabozantinib) Receive EC’s Approval for 1L Treatment of Advanced Renal Cell Carcinoma Read More »

Roche’s Tecentriq Receives CHMP’s Positive Opinion for 1L Treatment for Metastatic Non-Small Cell Lung Cancer

Shots: The CHMP’s recommendation is based on Phase III IMpower110 study assessing Tecentriq vs CT  in 572 PD-L1-selected, CT-naïve participants in a ratio (1:1) with stage IV non-squamous or squamous NSCLC Results: OS in people with high PD-L1 expression (7.1 vs 3.1mos.); safety profile is consistent with the current profile & no new safety signals …

Roche’s Tecentriq Receives CHMP’s Positive Opinion for 1L Treatment for Metastatic Non-Small Cell Lung Cancer Read More »

Innovent’s Tyvyt (sintilimab) + Pemetrexed and Platinum CT Receives NMPA’s Approval as 1L Therapy with Non-squamous Non-Small Cell Lung Cancer

Shots: The approval follows P-III ORIENT-11 study assessing Tyvyt (sintilimab) vs PBO + Almita (pemetrexed) and platinum CT in 397 participants in a ratio (2:1) as 1L therapy for advanced or recurrent nsqNSCLC Results: Improvement in PFS, as assessed by IRC; mPFS (8.9 vs 5.0mos.); safety profile is consistent with previously reported studies with no …

Innovent’s Tyvyt (sintilimab) + Pemetrexed and Platinum CT Receives NMPA’s Approval as 1L Therapy with Non-squamous Non-Small Cell Lung Cancer Read More »

Merck’s Keytruda (pembrolizumab) Receives EC’s Approval as 1L Treatment for Metastatic Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer

Shots: The approval is based on pivotal P-III KEYNOTE-177 study involves assessing of Keytruda (200mg, q3w) vs CT regimen in 307 patients in a ratio (1:1) with previously untreated metastatic MSI-H or dMMR colorectal cancer Results: reduction in the risk of disease progression or death by 40%, median PFS (16.5mos. vs 8.2mos); ORR (44% vs …

Merck’s Keytruda (pembrolizumab) Receives EC’s Approval as 1L Treatment for Metastatic Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer Read More »

Exelixis Cabometyx (cabozantinib) + Opdivo (nivolumab) Receives US FDA’s Approval as a 1L Treatment for Patients with Advanced Renal Cell Carcinoma

Shots: The approval is based on results from CheckMate -9ER, P-III pivotal trial involves assessing of Cabometyx + Opdivo vs sunitinib in 651 patients previously untreated advanced or metastatic RCC. Results: @ median follow-up of 18.1 mos. patients treated with the combination achieved PFS of 16.6 mos vs 8.3 mos for Sutent arm. Opdivo + …

Exelixis Cabometyx (cabozantinib) + Opdivo (nivolumab) Receives US FDA’s Approval as a 1L Treatment for Patients with Advanced Renal Cell Carcinoma Read More »

Takeda’s Alunbrig (brigatinib) Receives MHLW’s Approval as a 1L and 2L Treatment for ALK+ Advanced or Recurrent NSCLC

Shots: The approval is based on P-II Brigatinib-2001 (J-ALTA) assessing Alunbrig in 72 Japanese patients with ALK+ NSCLC and P-III AP26113-13-301 (ALTA-1L) study assessing Alunbrig (180mg, qd with seven-day lead-in at 90mg, qd) vs crizotinib (250mg, bid) in 275 patients with ALK+ advanced NSCLC prior not treated with an ALK inhibitor The therapy showed effectiveness …

Takeda’s Alunbrig (brigatinib) Receives MHLW’s Approval as a 1L and 2L Treatment for ALK+ Advanced or Recurrent NSCLC Read More »

GSK’s Zejula (niraparib) Receives Health Canada Approval for 1L Treatment of Women with Advanced Ovarian Cancer

Shots: The approval is based on P-III PRIMA study assessing Zejula in patients with newly diagnosed advanced ovarian cancer with complete/partial response to Pt.-based CT regardless of biomarker status The therapy is now approved in Canada for monothx. treatment of female adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are …

GSK’s Zejula (niraparib) Receives Health Canada Approval for 1L Treatment of Women with Advanced Ovarian Cancer Read More »

Roche’s Tecentriq + Bevacizumab Receive Health Canada’s Approval as 1L Treatment for Unresectable or Metastatic Hepatocellular Carcinoma

Shots: The approval is based on P-III IMbrave150 study assessing Tecentriq (1200 mg) + bevacizumab (15 mg/kg, q3w, IV) vs sorafenib (400mg, bid) in 501 patients in a ratio (2:1) with unresectable or metastatic HCC, prior not treated with systemic therapies Results: 42% reduction in risk of death (OS); 41% reduction the risk of disease …

Roche’s Tecentriq + Bevacizumab Receive Health Canada’s Approval as 1L Treatment for Unresectable or Metastatic Hepatocellular Carcinoma Read More »

AstraZeneca and Merck & Co’s Lynparza Receive the US FDA’s Approval as a 1L Maintenance Treatment of Germline BRCA-Mutated Metastatic Pancreatic Cancer

Shots: The approval follows the US FDA Oncologic drugs Advisory Committee (ODAC) on 17 Dec based on P-III POLO trial, which involves assessing of Lynparza tablets (300 mg bid) as maintenance monothx vs. PBO in 154 patients in ratio (3:2) with gBRCAm metastatic pancreatic cancer whose disease had not progressed on at least 16 weeks …

AstraZeneca and Merck & Co’s Lynparza Receive the US FDA’s Approval as a 1L Maintenance Treatment of Germline BRCA-Mutated Metastatic Pancreatic Cancer Read More »