Shots: The P-III trial involves assessing Libtayo (300mg, IV, q3w) as monothx. vs CT in patients with recurrent or metastatic cervical cancer that has progressed on platinum-based CT. The trial enrolled patients regardless of their PD-L1 status The results demonstrated a 31% reduction in the risk of death in the total population, improvement in OS, […]Read More
Shots: The IDMC has recommended stopping the enrollment in the P-III COMET-ICE trial due to evidence of profound efficacy. The study involves assessing VIR-7831 (GSK4182136) vs PBO in 583 patients for the early treatment of COVID-19 in adults at high risk of hospitalization The results demonstrated an 85% reduction in hospitalization or death and were […]Read More
Shots: The NMPA has approved Lee pharma to initiate P-III clinical trials to evaluate Socazolimab + CT as a 1L treatment of ES-SCLC. The study is expected to initiate patient recruitment in Q2’21 The clearance is based on the results from P- Ib trial in which Socazolimab + carboplatin and etoposide demonstrated a promising efficacy […]Read More
Shots: The P-III BRAVE-AA2 study involves assessing Baricitinib (2mg & 4mg, qd) vs PBO in 546 adults with a SALT score ≥ 50 (i.e., who had ≥50% scalp hair loss) and a current episode of severe AA lasting at least 6mos. but no >8yrs. The P-III study met its 1EPs @36wks. and demonstrated significant improvement […]Read More
Shots: The P-III 20120215 study involves assessing of Blincyto vs SoC consolidation CT before alloHSCT in pediatric patients with high-risk first relapsed B-cell ALL. The findings were published in JAMA Results: @median follow-up 22.4mos., patients that are alive and event-free (69% vs 43%); patients achieved MRD negative remission (93% vs 24%); @36mos. OS was (81.1% […]Read More
Shots: The US FDA agreed to advance VERU-111 into a P-III study which will evaluate VERU-111 vs PBO in ~400 hospitalized patients in a ratio (2:1) with COVID-19 and are at high risk for ARDS. The study is anticipated to begin in Apr’2021 with clinical results expected in Q4’21 The P-II trial has demonstrated clinically […]Read More
Shots: The P-III NAVIGATOR study involves assessing Tezepelumab + SOC vs PBO + SOC in 1061 adults (18–80yrs.) & adolescents (12–17yrs.) with severe, uncontrolled asthma, who were receiving treatment with medium/high dose ICS + at least 1 additional controller medication with/ out OCS The trial met its 1EPs i.e. 56% reduction in AAER @52wks. in […]Read More
Shots: Regeneron reported changes to the P-III study assessing REGEN-COV in non-hospitalized patients with COVID-19, following recommendations from the IDMC The IDMC found clear clinical efficacy in reducing the rate of hospitalization and death with both doses (1,200 & 2,400 mg) of REGEN-COV vs PBO. The company will immediately stop enrolling patients in the PBO […]Read More
Shots: The P-III U-ACCOMPLISH induction study involves assessing upadacitinib (45 mg, qd) vs PBO in patients with mod. to sev. UC The study met its 1EPs @8wks. i.e, patients achieved clinical remission (per Adapted Mayo Score) (31% vs 4%); met its 2EPs i.e clinical response @8wks. & @2wks. (74% vs 25% & 63% vs 26%); […]Read More
Shots: The P-III study evaluates the efficacy and safety of TX05 vs Herceptin (trastuzumab) in patients with human epidermal growth factor receptor 2-positive early breast cancer The 1EPs was an assessment of pCR following neoadjuvant therapy and definitive surgery in the per-protocol population Results: Patients achieved pCR (48.8% vs 45.3%) in the per-protocol population Click […]Read More
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