Diskusjon Triggere Porteføljer Aksjonærlister

Forskningsresultater og klinisk/regulatorisk praksis

Her kan vi legge ut linker og tanker rundt resultater fra kliniske studier. Kan være en interessent idé å få samlet nye resultater for å holde oversikt over det i markedet som er relevant.

Dette er i resectable melanoma, altså operabel føflekkreft.

The addition of Yervoy to Opdivo in this trial did not result in a statistically significant improvement in recurrence-free survival (RFS) in the all-comer (intent-to-treat) population.

6 Likes

Metastatic Non-Small-Cell Lung Cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up

https://www.esmo.org/guidelines/lung-and-chest-tumours/clinical-practice-living-guidelines-metastatic-non-small-cell-lung-cancer

Atezolizumab for First-Line Treatment of PD-L1–Selected Patients with NSCLC

RESULTS

Overall, 572 patients were enrolled. In the subgroup of patients with EGFR and ALK wild-type tumors who had the highest expression of PD-L1 (205 patients), the median overall survival was longer by 7.1 months in the atezolizumab group than in the chemotherapy group (20.2 months vs. 13.1 months; hazard ratio for death, 0.59; P=0.01). Among all the patients who could be evaluated for safety, adverse events occurred in 90.2% of the patients in the atezolizumab group and in 94.7% of those in the chemotherapy group; grade 3 or 4 adverse events occurred in 30.1% and 52.5% of the patients in the respective groups. Overall and progression-free survival favored atezolizumab in the subgroups with a high blood-based tumor mutational burden.

1 Like


- Lilly submitted request for emergency use authorization (EUA) for monotherapy to U.S. Food and Drug Administration (FDA)
- New data show combination therapy met primary and secondary endpoints, reducing viral load, symptoms and hospitalizations; EUA request to follow
- Plan to initiate a large open-label pragmatic study in COVID-19 outpatients in October

1 Like

Dagens behandling for brystkreft med spredning

Greit å vite…

https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-covid-19

Har du funnet noe relevant til våre selskaper?

Ja. For eksempel: Ultimovacs stod for noen år siden over å planlegge en registreringsstudie i lungekreft på grunn av at sjekkpunkthemmere ikke hadde fått fotfeste i indikasjonen.

Det lover godt at vi ser det endrer seg både i Europa og USA.

1 Like

tygger på den, ty.

KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) Demonstrated Statistically Significant Improvement in Progression-Free Survival (PFS), Overall Survival (OS) and Objective Response Rate (ORR) Versus Sunitinib as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma

Five-Year Outcomes From the Randomized, Phase III Trials CheckMate 017 and 057: Nivolumab Versus Docetaxel in Previously Treated Non–Small-Cell Lung Cancer

RESULTS

After the minimum follow-up of 64.2 and 64.5 months for CheckMate 017 and 057, respectively, 50 nivolumab-treated patients and nine docetaxel-treated patients were alive. Five-year pooled OS rates were 13.4% versus 2.6%, respectively; 5-year PFS rates were 8.0% versus 0%, respectively. Nivolumab-treated patients without disease progression at 2 and 3 years had an 82.0% and 93.0% chance of survival, respectively, and a 59.6% and 78.3% chance of remaining progression-free at 5 years, respectively. Treatment-related adverse events (TRAEs) were reported in 8 of 31 (25.8%) nivolumab-treated patients between 3–5 years of follow-up, seven of whom experienced new events; one (3.2%) TRAE was grade 3, and there were no grade 4 TRAEs.

Dette måtte da kunne vært mulig å få til noe i denne populasjonen, @polygon ?? Klokkeklart rasjonale.
'"Patients (N = 854; CheckMate 017/057 pooled) with advanced NSCLC, ECOG PS ≤ 1, and progression during or after first-line platinum-based chemotherapy "

2 Likes

Ingen tvil om at både BMS og Merck vil være fryktelig interesserte i å gi sine respektive PD-1 sjekkpunkthemmere en edge i denne indikasjonen. Begge er en del av SoC, og det er veldig lik effekt, noe denne ganske nye retrosepektive studien konkluderer med:

https://www.nature.com/articles/s41598-020-70207-7

1 Like

https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(20)30641-0/fulltext

ipi+nivo ble i fjor også godkjent i to regimer under NSCLC ja. Men pembrolizumab og nivolumab alene er fortsatt en del av SoC. Så dette betyr fortsatt ingen vinner der, tror jeg. Men nå beveger jeg meg på veldig tynn is, så fint om @Boykie , @Bra_Britt eller andre kunne rydde opp/mene noe om dette. Dette er vel relevant for flere av de norske biotekene?

1 Like