Shots: The companies collaborated to evaluate Hookipa’s HB-200 (arenaviral immunotherapeutic) + Merck’s Keytruda (anti-PD-1 therapy) in a P-II trial for patients with advanced HNSCC, based on an ongoing P-I/II trial of HB-200 for advanced HPV16+ cancers patients HB-201 monothx. showed an ORR (18%), m-PFS (3.45mos.) in heavily pretreated head & neck cancer patients. Preliminary data […]Read More
Shots: The companies collaborated to evaluate IO’s IO102-IO103 + MSD’s Keytruda vs Keytruda alone in the P-III trial for patients with previously untreated unresectable or MM. Biomarker studies will also be conducted while IO will sponsor the trial & MSD will provide Keytruda The P-I/II trial of combination therapy in 30 patients with the same […]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 P-III CHOICE-01 trial evaluates toripalimab + CT vs CT alone in 465 patients in a ratio (2:1) with advanced sq./nonsq. NSCLC without driver mutations The interim analysis met its 1EPs i.e., improvement in PFS, superior ORR & DoR, OS data are still maturing. The safety profile was consistent with PD-1 inhibitor while final […]Read More
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 […]Read More
Shots: The P-III POSEIDON trial evaluates Imfinzi (1500mg, q3w, FD, for 4 cycles) + Pt-based CT or Imfinzi + Tremelimumab + CT vs CT alone in 1013 patients with mNSCLC The results showed an improvement in OS & PFS, 28% reduction in risk of cancer progressing or death with an m-PFS (6.2 vs 4.8mos.), 23% […]Read More
Shots: The P-III study evaluates Byooviz (0.5 mg, IVT) vs ranibizumab in 634 patients with nAMD. The results will be presented at EURETINA 2021 The 1EPs are changed from baseline in BCVA @8wks. and change in CST @4wks. with both EPs, followed by 52wks. The post-hoc analysis showed that the baseline age, BCVA, CST, and […]Read More
Shots: The first patient has been dosed in a P-III program that consists of P-III ADORING 1/2 and long-term extension ADORING 3 study evaluates the safety and efficacy of tapinarof (1% dosed, qd) vs vehicle-controlled cream in patients aged ≥2yrs. with AD The 1EPs of ADORING 1/2 studies will be the proportion of patients achieving […]Read More
Shots: The P-Ib/II trial evaluates the safety and preliminary efficacy of onvansertib + Folfiri and Avastin in 2L treatment of patients with KRAS-mutated mCRC As of July 2, 2021, 42% patients achieved a partial response at RP2D (15 mg/m2 dose); confirmed PR (37%); ORR (5-13%); mPFS has not yet reached. Additionally, 38% patients achieved an […]Read More
Shots: The P-III MANDALA & DENALI trial evaluates the efficacy & safety of PT027 (180/160mcg & 180/80mcg doses) vs albuterol & albuterol and budesonide aged ≥4yrs. in 3132 & 1001 patients with asthma Both trials met its 1EPs i.e., reductions in risk of severe exacerbations in the MANDALA trial, improvement in lung function as measured […]Read More
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