Tags : NSCLC

Regulatory

Takeda’s Mobocertinib (TAK-788) Receives the US FDA’s Breakthrough Therapy Designation

Shots: Shots: The BT designation is based on P-I/II study assessing the safety and efficacy of mobocertinib (160mg, qd) in patients with LA/ m NSCLC, harboring EGFR exon 20 insertion mutations, prior treated with systemic CT The P-I/II ongoing study results: mPFS (7.3mos.); ORR (43%); safety profile was manageable. The mobocertinib development program began in […]Read More

Biosimilars

Bio-Thera Reports Results of BAT1706 (biosimilar, bevacizumab) in P-III Trial

Shots: The P-III study involves assessing of BAT1706 vs EU Avastin (bevacizumab) + chemotherapy in patients with non-squamous NSCLC, evaluating its safety, efficacy, PK & immunogenicity The trial resulted in meeting its 1EPs and demonstrated the equivalence in ORR for 1L patients with advanced non-squamous NSCLC BAT1706 is mAb & second biosimilar in Bio-Thera’s portfolio […]Read More

Regulatory

Merck KGaA’s Tepotinib Receives FDA’s Breakthrough Therapy Designation for Metastatic

Shots: The BT designation is based on ongoing VISION study (NCT02864992) assessing Tepotinib in 73 patients with m-NSCLC harboring MET exon 14 skipping alterations detected by liquid biopsy (LBx) or tissue biopsy (TBx) across different lines of treatment The VISION study results: ORR and DOR for LBx identified patients assessed by IRC & investigator (50% […]Read More

Regulatory

Merck’s Keytruda + Chemotherapy Receive EU’s Approval for Metastatic Squamous

Shots: The approval is based on P-III KEYNOTE-407 study assessing Keytruda + carboplatin/nab paclitaxel vs carboplatin/nab paclitaxel monothx. in ratio (1:1) in patients with msqNSCLC regardless of PD-L1 expression  The P-III KEYNOTE-407 results: ORR (58% vs 38%); mDOR (7.7mos. vs 4.8mos.); improves PFS with reduction in death (44%), improvement in OS (36%) Keytruda (pembrolizumab) 200mg […]Read More

Pharma

Merck’s KEYTRUDA (pembrolizumab) Receives CHMP Recommendation for 1L Metastatic Squamous

Shots: The positive opinion is based on P-III KEYNOTE-407 trials results assessing Keytruda + CT (carboplatin/paclitaxel/nab-paclitaxel) vs CT monothx. in patients with msq NSCLC The P-III KEYNOTE-407 trials resulted in improved OS & PFS and demonstrated rates of alopecia (47% vs 36%) and peripheral neuropathy (31% vs 25%), were presented at ASCO 2018 Keytruda (pembrolizumab) […]Read More

Biosimilars Biotech

Innovent Biologics Reports Acceptance of BLA for IBI-305 (bevacizumab, biosimilar)

Shots: The BLA is based on two P-III study results assessing efficacy, safety and PK of IBI-305 vs bevacizumab in patients with advanced non-sq NSCLC and has demonstrated in meeting 1EPs with bio-similarity Innovent has received three NMPA acceptance including IBI-305 namely Tyvyt (sintilimab injection) and IBI-303 (adalimumab, biosimilar) in H2’18 for ankylosing spondylitis (AS), […]Read More