Shots: The two P-III studies (COUGH-1 &-2) involves assessing of gefapixant (45mg, 15mg, bid) vs PBO in 732 & 1,317 patients with refractory or unexplained chronic cough with 1EP as 24hrs. cough/hr. @12wks. and 24wks. respectively Gefapixant (45mg, bid) arm met its 1EPs i.e, decrease in 24hrs. coughs/hr. @12wks. & 24wks. while gefapixant (15mg, bid) […]Read More
Shots: The P-III CASPIAN study involves assessing of Imfinzi + SOC (etoposide and carboplatin/ cisplatin CT) or Imfinzi + Tremelimumab vs CT as monothx. as a 1L treatment for 805 patients with ES-SCLC in 200+ centers across 23 countries The first arm (Imfinzi + SOC) has met its 1EPs of OS in Jun’2019 while the […]Read More
Shots: The P-III GY004 study involves assessing of cediranib + Lynparza vs Lynparza as monothx. vs standard platinum-based CT in patients with recurrent platinum-sensitive OC, fallopian tube, or primary peritoneal cancer patients, with/without a BRCA mutation The P-III GY004 study resulted in not meeting its 1EPs in IIT population i.e. an improvement in PFS when […]Read More
Shots: The P-III TOURMALINE-MM2 study involves assessing of Ninlaro + lenalidomide + dexamethasone vs PBO + lenalidomide + dexamethasone in 705 transplant-ineligible patients with newly diagnosed MM The P-III TOURMALINE-MM2 study results: improvement in PFS (35.3 mos. vs 21.8 mos.); safety profile is consistent with the existing prescribing information Ninlaro is an oral proteasome inhibitor, […]Read More
Shots: The P-III ELOQUENT-1 study involves assessing of Empliciti (elotuzumab)+ Revlimid (lenalidomide) and dexamethasone (ERd) vs Rd in transplant-ineligible patients with newly diagnosed, previously untreated MM The P-III ELOQUENT-1 study resulted in not meeting its 1EPs of PFS while the safety profile of ERd is consistent with its known profiles Empliciti is an immunostimulatory Ab […]Read More
Shots: The P-III DANUBE study involves assessing Imfinzi as monothx. & Imfinzi + Tremelimumab vs SOC CT as a 1L treatment for patients with unresectable, Stage IV (metastatic) UC whose tumor cells express high levels (≥25%) of PD-L1 & patients regardless of their PD-L1 expression respectively The P-III DANUBE study did not meet its 1EPs […]Read More
Shots: The P-II/III ARTISTS 1 & P-III ARTISTS 2 studies involve assessing of Austedo vs PBO in 119 & 158 pediatric patients (6-16 yrs.) in a ratio (1:1) & (1:1:1) over 12 & 8wks. dosing for the treatment of tics in patients with mod. to severe TS The P-II/III ARTISTS 1 & P-III ARTISTS 2 […]Read More
Shots: The clinical study involves assessing HeadaTerm TENS therapy in patients that were divided into two groups: a sham group & a verum group, both the groups underwent therapy for 20mins The clinical study results: change in VAS from 0 to 120mins (-65.46 ± 25.11 & -9.46 ± 2.61); verbal score @120mins. (1.2 & 4.5); […]Read More
Shots: The clinical study involves assessing the PK, efficacy, and safety of CT-P13 SC vs CT-P13 IV in 131 patients with active CD & UC for 1yr. Following loading doses of IV 5mg/kg @0 & 2wks., patients were randomized @6wks. to receive either SC 120/240 mg q2w or continued IV 5 mg/kg q8w, @30wks. IV […]Read More
Shots: The P-III KEYNOTE-355 (part 1 & 2) study involves assessing of Keytruda (200mg, IV, on day 1 of each 21-day cycle) + CT vs PBO + CT in 30 & 847 patients with LA inoperable or mTNBC prior not treated with CT in the metastatic setting The P-III KEYNOTE-355 study resulted in meeting one […]Read More
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