Tags : Advanced

STADA Expands its Specialty Footprint with the Acquisition of Lobsor

Shots:   STADA acquires Lobsar and its innovative therapy to foster its footprints in specialty pharmaceuticals. The acquisition complements STADA’s portfolio and expertise in the treatment of late-stage Parkinson’s disease With the acquisition, STADA gain rights to a triple fixed combination (levodopa/carbidopa/ entacapone) delivered via modern pump technology, already launched in Nordic countries Levodopa, carbidopa and […]Read More

Roche’s Tecentriq + Cotellic and Zelboraf Receives the US FDA’s

Shots: The approval is based on P-III IMspire150 study assessing Tecentriq (atezolizumab) + Cotellic  (cobimetinib) + Zelboraf (vemurafenib) vs  PBO + Cotellic +   Zelboraf in patients with BRAF V600 mutation-positive advanced melanoma Results: mPFS (15.1 vs 10.6mos.); the safety profile of the Tecentriq combination was consistent with the known safety profiles of the individual medicines. […]Read More

Oncorus Initiates P-I Study of ONCR-177 in Patients with Advanced/

Shots: Oncorus has initiated a P-I study assessing ONCR-177 as monothx. and in combination with Merck’s Keytruda in patients with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors The P-I study enrolls ~21 cancer patients while P-II study enrolls patients to histology- specific expansion cohorts. The P-I study will evaluate the safety and […]Read More

Roche Reports Results of Tecentriq in P-III IMagyn050 Study for

Shots: The P-III IMagyn050 study involves assessing of Tecentriq + Avastin, paclitaxel, and carboplatin vs PBO + Avastin, paclitaxel and carboplatin in the ratio (1:1) in women with Stage III or IV ovarian cancer who are undergoing neoadjuvant or adjuvant therapy The study did not meet its 1EP i.e. PFS while the safety data were consistent […]Read More

BMS’ Opdivo (nivolumab) Receives the US FDA’s Approval for Advanced

Shots: The US FDA’s approval is based on P-III ATTRACTION-3 study assessing Opdivo (240mg by IV infusion over 30min, q2w) vs taxane CT (docetaxel/paclitaxel) in patients with unresectable advanced, recurrent or ESCC, refractory/ intolerant to at least one prior fluoropyrimidine & platinum-based CT Opdivo is the first approved immunotherapy in this setting regardless of tumor […]Read More

BMS Signs a Clinical Trial Collaboration with UbiVac to Evaluate

Shots: The two companies collaborated to evaluate the safety, tolerability, and preliminary efficacy of UbiVac’s DPV-00 in combination with BMS’ anti-OX40 (BMS-986178) combined with Opdivo (nivolumab) The P-Ib study will test the hypothesis that combination immunotherapy with the DPV-001 vaccine and anti-OX40 will boost anticancer immunity in patients with advanced TNBC UbiVac’s DRibble Platform Vaccine, […]Read More

Celltrion and MSD Report Results of First-Line Triplet Regimen P-I/II

Shots: The P-I/II study involve assessing of pembrolizumab (IV, 200mg), Herzuma (biosimilar trastuzumab) (6mg/kg (after 8mg/kg load) D1 and CT in 43 patients with median follow up of 18 mons. In patients with HER2-positive advanced gastric cancer (AGC) P-I/II study results: tumor shrinkage of 95.3%, ORR of 76.7%, CR 16.3%, PR 60.5%, disease control rate […]Read More

Innovent and Eli Lilly Report Results of TYVYT (sintilimab) in

Shots:sstosohShots: The P-II ORIENT-2 study involves assessing TYVYT as monothx. vs paclitaxel/ rinotecan in 190 patients in a ratio (1:1) with advanced or metastatic ESCC who failed 1L treatment The P-II ORIENT-2 resulted in meeting its 1EPs of OS with no news safety signals. The detailed results will be presented at ASCO 2020. The two […]Read More

Seattle’s TUKYSA (tucatinib) Receives the US FDA’s Approval for Advanced

Shots: The approval is based on HER2CLIMB study assessing TUKYSA in combination with trastuzumab and capecitabine vs trastuzumab & capecitabine monothx in ratio (2:1) in 612 patients with 1L+ Anti-HER2 therapies in the metastatic setting either monothx or in combination, trastuzumab, pertuzumab, and ado-trastuzumab emtansine (T-DM1) The study resulted in 46% reduction in the risk […]Read More