Immunocore’s Tebentafusp Receives the US FDA’s Breakthrough Therapy Designation for Unresectable or Metastatic Uveal Melanoma

Shots:

  • The US FDA has granted BTD to the tebentafusp (IMCgp100) for the treatment of HLA-A*02:01-positive adult patients with unresectable/ mUM
  • The pre-planned interim analysis of a P-III study (IMCgp100-202) in prior untreated muM demonstrated superior OS as monothx. Immunocore will be working with the FDA to facilitate the submission of a BLA for the therapy
  • Tebentafusp is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function and has received the US FDA’s ODD and FTD and Promising Innovative Medicine designation under the UK Early Access to Medicines Scheme. If approved, tebentafusp would be the first new therapy in this space

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: Linkedin

The post Immunocore’s Tebentafusp Receives the US FDA’s Breakthrough Therapy Designation for Unresectable or Metastatic Uveal Melanoma first appeared on PharmaShots.

Janssen Reports Results of Amivantamab in P-I CHRYSALIS Study for Metastatic or Unresectable NSCLC and EGFR Exon 20 Insertion Mutations

Shots:

  • The P-I CHRYSALIS study involves assessing of amivantamab (RP2D of 1050 mg [1400 mg for a patient weight of ≥80 kg]) as a monothx. and in combination with lazertinib in 460 patients with metastatic or unresectable NSCLC and EGFR exon 20 insertion mutations whose disease progressed on or after platinum-based CT
  • Results: ORR (40%); mPFS (8.3 mos.); mOS (22.8 mos.), clinical benefit rate (74%), mDoR (11.1 mos.). The data showed robust activity and durable responses with a tolerable and manageable safety profile
  • The company has filed regulatory submissions in the US and EU seeking approval of amivantamab

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: The Pharma Letter

The post Janssen Reports Results of Amivantamab in P-I CHRYSALIS Study for Metastatic or Unresectable NSCLC and EGFR Exon 20 Insertion Mutations first appeared on PharmaShots.

EMA’s CHMP Recommends Four-Week Dosing Option for AstraZeneca’s Imfinzi to Treat Unresectable NSCLC

Shots:

  • AstraZeneca’s Imfinzi durvalumab (1500mg, fd, q4w) is recommended for approval in the EU for an additional dosing option in the approved indication of LA, unresectable NSCLC in adults whose tumors express PD-L1 on at least 1% of tumor cells and whose disease has not progressed following platinum-based CRT
  • The CHMP opinion is based on P-III PACIFIC trial that supported the 2wk, weight-based dosing of 10mg/kg q2w already approved in LA, unresectable NSCLC & the P-III CASPIAN trial which used fd, q4w during maintenance treatment in ES-SCLC
  • The option would extend dosing from two to four weeks, reducing medical visits and improving patient convenience

Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: EORTC

The post EMA’s CHMP Recommends Four-Week Dosing Option for AstraZeneca’s Imfinzi to Treat Unresectable NSCLC first appeared on PharmaShots.

Roche’s Tecentriq + Bevacizumab Receive Health Canada’s Approval as 1L Treatment for Unresectable or Metastatic Hepatocellular Carcinoma

Shots:

  • The approval is based on P-III IMbrave150 study assessing Tecentriq (1200 mg) + bevacizumab (15 mg/kg, q3w, IV) vs sorafenib (400mg, bid) in 501 patients in a ratio (2:1) with unresectable or metastatic HCC, prior not treated with systemic therapies
  • Results: 42% reduction in risk of death (OS); 41% reduction the risk of disease worsening or death (PFS); @primary analysis, median survival follow up time (8.6mos.); 7.6mos. delay in median time to deterioration of patient-reported QoL
  • The approval is part of Project Orbis, an initiative of the FDA’s OCE which provides a framework for simultaneous submission and review of oncology products among international partners

Click here ­to­ read full press release/ article | Ref: Roche | Image: SOM