Hvilken studie da?
Den du refererte til fra Medwatch (datert 15. feb 2023) er ferdig:
https://www.annalsofoncology.org/article/S0923-7534(23)03308-2/fulltext
" Results:
The study enrolled 99 safety-evaluable pts; median age 65 years (range 39-86); 90 pts were efficacy-evaluable (EE). Most common adverse events were gastrointestinal disorders (G ≤2) in >20% of pts and transient liver enzyme increase (G ≤3) in 10% pts. Median (m) OS and mPFS were 13 and 6.2 months (mths), respectively. AXL status impacted mOS: 14.8 vs 9.9 mths (p=0.029) for AXL >5 vs AXL ≤5, respectively. No difference in mOS (10.6 vs 12.4 mths) or mPFS (6 vs 7 mths) in PD-L1+ (TPS≥1) vs PD-L1- (TPS<1) pts, respectively. The ORR of 11.1% in all EE pts and 21.9% in pts with AXL >5 favourably aligns with therapies in 2L NSCLC. Median OS and mPFS in KRAS mutated (KRASMT) (n=20) and KRAS wild-type (KRASWT)(n=36) were 14.1 vs 10.0 mths (p=0.49) and 9.8 vs 3.8 mths (p=0.009), respectively. The mOS and mPFS for the PD-L1- (n=6) and PD-L1+ (n=11) KRASMT pts were 18 vs 11.4 mths (p=0.017) and 17.3 vs 6.1 mths (p=0.09), respectively.
Conclusions
Bem+pembro was well tolerated and efficacious compared to historical controls. Survival benefit was observed in pts with AXL >5, regardless of prior therapy or PD-L1 status. The promising efficacy signal observed in KRASMT pts warrants further validation."
Kan noen fortelle meg om det er startet en ny studie for å skaffe den ovennenvte valideringen? Og kan noen fortelle / forklare meg hva fra disse resultatene eller konklusjonen som gjør at man vil investere penger i BGBIO? For det klarer ikke jeg å se.
For hudkreftstudien som Oddbjørn Straume presentert på ESMO i fjor høst (LBA52) er vel også ferdig?
https://cslide.ctimeetingtech.com/esmo2023/attendee/confcal/session/calendar?q=lba52
Sakser inn siste bit fra den også:
"Results
Patients were enrolled between 2017 and 2022. At the interim database lock on August 21 2023, median follow time was 53 months (10-78). A daily dose of 200 mg Bem was well tolerated in combinations with Pem or D/T; 24% (18/73) of Grade ≥ 3 AEs were regarded as related to Bem. Most frequent Bem-related AEs were rash, diarrhoea, fatigue and increased transaminases. In the efficacy population (n=70), we did not observe significant differences in ORR, PFS or OS between standard treatments and the combinations with Bem. In pre-planned analyses of baseline biomarkers, we did not identify subgroups of patients with increased response to combinations with Bem compared to standard treatment. The following biomarkers predicted improved ORR to Pem; high CD8+ count (p<0.01), high FOXP3 count (p<0.01), high PD-L1 in TIL (p=0.02), high AXL expression in inflammatory cells (p=0.04). High FOXP3 count (above median) in tumours, compared with low, predicted increased PFS in Pem treated patients (HR 0.2, p<0.01).
Conclusions
Bem was well tolerated in combinations with Pem or D/T in melanoma, but did not increase responses or survival in the efficacy population nor in biomarker defined subgroups. High FOXP3 count in tumour infiltrating inflammatory cells was a strong predictive marker for response to Pem."
Ikke noe økning i respons eller survival der.