Shots: The BT designation is based on P-II CodeBreaK 100 study assessing Sotorasib in 126 patients with KRAS G12C-mutated locally advanced or metastatic NSCLC who have received at least one prior systemic therapy. The findings will be presented at the IASLC 2020 WCLC Presidential Symposium The company is currently recruiting in a P-III study (CodeBreaK […]Read More
Shots: The P-II cohort of the CodeBreaK 100 clinical study involves assessing Sotorasib (AMG 510, 960mg, qd) in 126 patients with KRAS G12C-mutated advanced NSCLC. The findings will be presented at the IASLC 2020 WCLC Results: @median follow up of 12.2 mos., ORR (37.1%); DCR (80.6%); mDoR (10 mos.), PFS (6.8 mos.). Median tumor shrinkage […]Read More
In a recent interview with PharmaShots, Kiran Patel, Vice President Clinical Development, Solid Tumor Franchise at Janssen shared his views on the regulatory submission of Amivantamab for the Treatment of Patients with Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations. Shots: Janssen reported the BLA submission to the US FDA seeking approval […]Read More
Shots: The NDA submission is based P-II CodeBreaK 100 study assessing Sotorasib in patients with KRAS G12C-mutated NSCLC prior treated with CT and immunotherapy The study provided durable anticancer activity with a positive benefit-risk profile The US FDA has reviewed the NDA under RTOR pilot program, which aims to explore efficient review process that ensures […]Read More
Shots: AstraZeneca’s Imfinzi durvalumab (1500mg, fd, q4w) is recommended for approval in the EU for an additional dosing option in the approved indication of LA, unresectable NSCLC in adults whose tumors express PD-L1 on at least 1% of tumor cells and whose disease has not progressed following platinum-based CRT The CHMP opinion is based on […]Read More
Shots: The P-ll CodeBreaK 100 study involves assessing of Sotorasib (proposed INN for AMG 510, 960mg) in 126 patients with KRAS G12C-mutant advanced NSCLC, whose cancer had progressed despite prior treatment with CT and/or immunotherapy Result: ORR is consistent with previously reported P-I study while other measures of efficacy including DoR are promising and 50%+ […]Read More
Shots: The first patient has been dosed in the P-IIa expansion portion of P- I/IIa study, assessing BT1718 (qw) at RP2D of 20 mg/m2 in patients with MT1-MMP+ sq. NSCLC and a basket of other MT1-MMP+ solid tumors The focus of the study is to evaluate the safety and tolerability profiles of BT1718 while the […]Read More
Shots: The US FDA has accepted sBLA and granted PR to Imfinzi (1500mg) for a new 4wks. FD regimen to treat patients with unresectable Stage III NSCLC after CT and prior treated advanced bladder cancer, consistent with the approved dosing in ES-SCLC The company anticipates the PDUFA date in Q4’20. The sBLA is based on […]Read More
Shots: The approval is based on integrated analysis including data from 74 people with LA/ m-NTRK fusion-positive solid tumors (14 tumor types) & 161 people with ROS1+ NSCLC of the pivotal P-II STARTRK-2, P-I STARTRK-1 and P-I ALKA-372-001 trials, and data from the P-I/II STARTRK-NG study in pediatric patients Result: in NTRK fusion+ solid tumors, […]Read More
Shots: Shots: The BT designation is based on P-I/II study assessing the safety and efficacy of mobocertinib (160mg, qd) in patients with LA/ m NSCLC, harboring EGFR exon 20 insertion mutations, prior treated with systemic CT The P-I/II ongoing study results: mPFS (7.3mos.); ORR (43%); safety profile was manageable. The mobocertinib development program began in […]Read More
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