Shots: The companies collaborated to evaluate Mirati’s adagrasib (KRASG12C inhibitor) + Sanofi’s SAR442720 (SHP2 inhibitor) in P-I/II dose-escalation & expansion study in patients with previously-treated NSCLC & KRASG12C mutations Adagrasib & SAR442720 demonstrated an anti-tumor activity in pre-clinical models & both have complementary MoA Sanofi will be responsible for sponsoring & operating the P-I/II study & both […]Read More
Shots: The P-IIa study evaluates amlitelimab (IV, low/high dose, q4w over 12wks.) vs PBO in 88 patients with mod. to sev. AD inadequately controlled with topical therapies The co-primary EPs include @16wks., improvement in avg. EASI from baseline (80%/70% vs 49%) in LD/HD, no difference in responses was observed in both doses & the overall […]Read More
Shots: The P-IIb study evaluates the efficacy & safety of remibrutinib vs PBO in 311 patients with CSU inadequately controlled by H1-antihistamines for 12wks. The results showed an improvement in UAS7 related to CFB @4 & 12wks. & rapid improvement as of 1wks., patients achieved UAS7=0 (complete absence of hives & itch) and UAS7≤6 (well-controlled […]Read More
Shots: The P-IIb study evaluates ligelizumab (72/240mg) vs Xolair or PBO in patients with CSU with an inadequate control on antihistamines The results showed that proportion of patients achieved complete control of CSU symptoms @12 & 20wks. (44.1%/40.0% vs 23.5% & 0.0%) & (33.3%/34.1% vs 25.9% & 4.7%); CSU-free patients (38.1%/35.3% vs 18.8% & 0.0%) […]Read More
Shots: The RAINBOWFISH study evaluates the efficacy and safety of Evrysdi in babies aged birth to 6wks. with pre-symptomatic SMA The results showed that 4 out of 5 patients treated with Evrysdi for 12 mos. were able to stand & walk independently within the WHO windows for healthy children. Additionally, all five infants maintained the […]Read More
Shots: The P-I/II dose expansion studies evaluate the safety & preliminary anti-tumor efficacy of VT1021 as monothx. in patients with dose-escalation & expansion cohorts with rGBM & PC. The results of both studies are expected in Q4’21 In the rGBM expansion cohort, the therapy showed a complete tumor regression & PR, patients remain on trial […]Read More
Shots: The P-III study evaluates TX05 (biosimilar, trastuzumab) vs Herceptin in 809 patients with HER2-positive early-stage breast cancer The results showed that the proportions of patients that meet pCR criteria for equivalence were highly similar b/w TX05 (48.8%) and TRA (45.3%) cohorts; ORR (84.3%) & (85.0%); CR; PR and stable disease were also highly similar, […]Read More
Shots: The P-III study evaluates the efficacy, safety & immunogenicity of BCD-021 (q3w for 6 cycles) vs reference Avastin + paclitaxel & carboplatin in 357 patients with stage IIIB or IV nonsq. NSCLC across Russia, Belarus, Ukraine & India The study showed an equivalent efficacy, ORR (34.6% & 33.8%), 341 patients had 1 CT scan after initiation […]Read More
Shots: The P-II/III study evaluates opaganib +SoC vs PBO + SoC in a ratio (1:1) in 475 patients with COVID-19 pneumonia requiring hospitalization & treatment with supplemental oxygen The preliminary data showed that the study did not meet its 1EPs while efficacy EPs showed consistent trends. The therapy demonstrated good tolerability with balanced AEs & […]Read More
Shots: The AVT02-GL-302 study evaluates AVT02 in 568 patients at ~30 centers in the EU. Patients were randomized into either of the two arms of the switching module: The first group continues with Humira & the 2nd group is given AVT02 and Humira for an additional 16wks. The switching study (AVT02-GL-302) aims to support the […]Read More
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