PCI- H&N best LCM opportunity
Fullt fokus nå på fimaCHEM (GGK) og fimaVACC, som i Stuffers analyse tilsier med hhv 92% og 8% SOTP.
Vi vet likevel at det kan være et betydelig verdipotensiale i fimaNAC, med utrolig spennende avtaler, men også i fimaCHEM med H&N (head and neck cancer). Jeg tror at H&N står først på lista når GGK er godt i gang med PF2 og økonomien tilsier at LCM (life cycle management) av fimaCHEM kan settes i gang. Derfor på tide med en oppsummering.
Først bakgrunnen for den strategiske beslutningen for at H&N ble stoppet, og det ble satset på gallegangkreft, fra 2q15-rapporten:
http://pcibiotech.no/wp-content/uploads/2015/08/Q2-2015-Report.pdf
«Optimising intra-tumour illumination in recurrent and metastatic head and neck cancer has turned more time consuming than anticipated, and the complexity has further increased with the recent need to extend the treatment margin in the tumour rim. Recent updates on among others, checkpoint inhibitors (CPIs), also suggest that the competitive landscape for treatment of these patients will change dramatically in the near future. This will likely result in significantly increased competition for both clinical recruitment and market access, as well as a much higher risk for needing a large phase III study for regulatory approval of Amphinex in this indication. The increased technical complexity and the recent updates on competing products, caused the company to re-evaluate the competitive ability of Amphinex in recurrent head and neck cancer.”
Den konkurransen man da tenkte på var Keytruda, og en “basket trial” (klinisk forsøk med mange forskjellige krefttyper, hvorav H&N var en av de. (the KEYNOTE-012 trial).
Resultatet av KEYNOTE-012 ga Keytruda en midlertidig godkjennelse på H&N basert på at oppfølgingstudiet KEYNOTE-040 ble godkjent.
http://theoncologist.alphamedpress.org/content/early/2017/05/22/theoncologist.2016-0496.full.pdf
« On August 5, 2016, the U.S. Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA injection, Merck Sharp & Dohme Corp., Kenilworth, NJ) for treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. Approval was based on the objective response rate (ORR) and duration of response (DoR)
ORR was 16% (95% confidence interval 11, 22) with a complete response rate of 5%. DoR ranged from 2.41 months to 27.71 months. Twenty-three of 28 responding patients (82%) had response durations of 6 months. Safety was evaluated in 192 patients with HNSCC receiving at least one dose of pembrolizumab
As a condition of accelerated approval, Merck is required to conduct a confirmatory trial this trial, KEYNOTE-040, is ongoing."
Vi vet likevel at det kan være et betydelig verdipotensiale i fimaNAC, med utrolig spennende avtaler, men også i fimaCHEM med H&N (head and neck cancer). Jeg tror at H&N står først på lista når GGK er godt i gang med PF2 og økonomien tilsier at LCM (life cycle management) av fimaCHEM kan settes i gang. Derfor på tide med en oppsummering.
Først bakgrunnen for den strategiske beslutningen for at H&N ble stoppet, og det ble satset på gallegangkreft, fra 2q15-rapporten:
http://pcibiotech.no/wp-content/uploads/2015/08/Q2-2015-Report.pdf
«Optimising intra-tumour illumination in recurrent and metastatic head and neck cancer has turned more time consuming than anticipated, and the complexity has further increased with the recent need to extend the treatment margin in the tumour rim. Recent updates on among others, checkpoint inhibitors (CPIs), also suggest that the competitive landscape for treatment of these patients will change dramatically in the near future. This will likely result in significantly increased competition for both clinical recruitment and market access, as well as a much higher risk for needing a large phase III study for regulatory approval of Amphinex in this indication. The increased technical complexity and the recent updates on competing products, caused the company to re-evaluate the competitive ability of Amphinex in recurrent head and neck cancer.”
Den konkurransen man da tenkte på var Keytruda, og en “basket trial” (klinisk forsøk med mange forskjellige krefttyper, hvorav H&N var en av de. (the KEYNOTE-012 trial).
Resultatet av KEYNOTE-012 ga Keytruda en midlertidig godkjennelse på H&N basert på at oppfølgingstudiet KEYNOTE-040 ble godkjent.
http://theoncologist.alphamedpress.org/content/early/2017/05/22/theoncologist.2016-0496.full.pdf
« On August 5, 2016, the U.S. Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA injection, Merck Sharp & Dohme Corp., Kenilworth, NJ) for treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. Approval was based on the objective response rate (ORR) and duration of response (DoR)
ORR was 16% (95% confidence interval 11, 22) with a complete response rate of 5%. DoR ranged from 2.41 months to 27.71 months. Twenty-three of 28 responding patients (82%) had response durations of 6 months. Safety was evaluated in 192 patients with HNSCC receiving at least one dose of pembrolizumab
As a condition of accelerated approval, Merck is required to conduct a confirmatory trial this trial, KEYNOTE-040, is ongoing."
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