Tags : 1L

GSK’s Zejula (niraparib) Receives Health Canada Approval for 1L Treatment

Shots: The approval is based on P-III PRIMA study assessing Zejula in patients with newly diagnosed advanced ovarian cancer with complete/partial response to Pt.-based CT regardless of biomarker status The therapy is now approved in Canada for monothx. treatment of female adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are […]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

Roche’s Tecentriq Receives the US FDA’s Approval as 1L Monotherapy

Shots: The US FDA has approved Tecentriq (atezolizumab) as a 1L Treatment for adults with metastatic NSCLC whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells or PD-L1 stained tumor-infiltrating covering ≥ 10% of the tumor area), as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations […]Read More

GSK’s Zejula (niraparib) Receives the US FDA’s Approval as 1L

Shots: The approval is based on P-III PRIMA study assessing Zejula (300/200mg, qd) vs PBO in patients with newly diagnosed advanced ovarian cancer following complete or partial response to platinum-based CT regardless of biomarker status The P-III PRIMA study resulted in a 57% improvement in PFS in HRd population and a 38% reduction in the […]Read More

Cue Biopharma Signs Clinical Trial Collaboration with Merck to Evaluate

Shots: Cue Biopharma will conduct a P-I KEYNOTE-A78 study assessing the combination therapy as 1L treatment for HPV+ advanced head and neck cancer. KEYNOTE-A78 will be conducted in parallel with the ongoing P-I study assessing CUE-101 as monothx. post 1L treatment The ongoing P-I dose-escalation and expansion study assessing CUE-101 as a monothx. in post […]Read More