Diskusjon Triggere Porteføljer Aksjonærlister

Forskningsresultater og klinisk/regulatorisk praksis

Biotek
#23

Genentech Provides Update on Tecentriq U.S. Indication in Prior-Platinum Treated Metastatic Bladder Cancer
South San Francisco, CA – March 7, 2021 –

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the company is voluntarily withdrawing the U.S. indication for Tecentriq® (atezolizumab) in prior-platinum treated metastatic urothelial carcinoma (mUC, bladder cancer). This decision was made in consultation with the U.S. Food and Drug Administration (FDA) as part of an industry-wide review of accelerated approvals with confirmatory trials that have not met their primary endpoint(s) and have yet to gain regular approvals. Genentech will work with the FDA over the coming weeks to complete the withdrawal process. This decision does not affect other approved indications for Tecentriq

1 Like
#24

PURPOSE

It remains controversial whether primary tumor resection (PTR) before chemotherapy improves survival in patients with colorectal cancer (CRC) with asymptomatic primary tumor and synchronous unresectable metastases.

CONCLUSION

Given that PTR followed by chemotherapy showed no survival benefit over chemotherapy alone, PTR should no longer be considered a standard of care for patients with CRC with asymptomatic primary tumors and synchronous unresectable metastases.

#25

Bristol Myers Squibb (NYSE: BMY) today announced primary results from the Phase 2/3 RELATIVITY-047 (CA224-047) trial evaluating the fixed-dose combination of relatlimab, an anti-LAG-3 antibody, and Opdivo (nivolumab) versus Opdivo alone in patients with previously untreated metastatic or unresectable melanoma. The trial met its primary endpoint of progression-free survival (PFS). Follow up for overall survival, a secondary endpoint, is ongoing. The fixed-dose combination was well-tolerated and there were no new safety signals reported in either the relatlimab and Opdivo combination arm or the Opdivo arm. These are the first Phase 3 data to be reported from a trial evaluating an anti-LAG-3 antibody. Relatlimab is the third distinct checkpoint inhibitor (anti-PD-1, anti-CTLA-4 and anti-LAG-3) for Bristol Myers Squibb and, with Opdivo, the first fixed-dose combination to demonstrate a benefit for patients.

1 Like
#26

https://www.massgeneral.org/news/press-release/Study-reveals-crucial-details-on-skin-related-side-effects-of-cancer-immune-therapies

1 Like
#27

Noen som tror det blir mindre viktig fremover for disse selskapene å finne gode medikamenter å kombinere med?

#28

Denne passer vel bra her også

2 Likes
Nordic Nanovector - Småprat 2 2020 - 2021 (NANOV) 1
#29

Absolutt. Jeg endret trådtittelten til å reflektere det bedre.

Ganske interessant forslag, og høyaktuelt for flere av de norske vil jeg si. Paradigme kunne vel fort blitt en kandidat for durable ORR som støtte for full godkjenning av Betalutin f.eks.

1 Like
#30

http://know.lww.com/nsclc/articles/nivolumab-chemo.html

Nivolumab plus chemotherapy significantly improved pathological complete response rates compared to chemotherapy alone in patients with resectable stage Ib-IIIa non-small cell lung cancer (NSCLC), according to findings presented at the AACR Annual Meeting 2021.

Data from the Phase III CheckMate-816 trial showed neoadjuvant treatment with 3 cycles of nivolumab plus chemotherapy resulted in a pathologic response rate of 24 percent versus 2.2 percent in patients given chemotherapy alone, with no increase in overall toxicity or delays to surgery.

#31
#32

How we treat locoregional melanoma

https://www.esmoopen.com/article/S2059-7029(21)00095-8/fulltext

1 Like
#33

FDA har begynt å trekke tilbake accelerated approvals hvor det ikke finnes klinisk nytte i OS.

Neste steg for CPI-produsentene må være å finne den beste kombinasjonen.

2 Likes
#34

Har forstått det slik at det tidligere har vært heller skjelden at FDA har trukket tilbake en betinget/midlertidig markedsføringstillatelse. Men helt forståelig og riktig at så skjer dersom ikke post-market-data holder mål.

Nettopp dette med å finne fulltrefferkombinasjonen gjelder bl.a. når PCIBs fimaVACC både skal kombineres med en kreftvaksine og en immunmodulator som f.eks. en CPI.

#35

Ja, det er flere strategier blant de norske selskapene.

Targovax ønsker å gjøre sjekkpunkthemmer-refraktære pasienter til respondere igjen.
Ultimovacs ønsker å bevise at UV1 kan kombineres med alle de største sjekkpunkthemmerne i veldig mange indikasjoner.
BerGenBio ønsker å vise at AXL-hemming og PD1-hemming gir synergistisk effekt i pasienter som har kreft som uttrykker AXL.
Vaccibody TROR jeg, ønsker å gjøre VB10.NEO til den beste presisjonsmedisinen - og jeg gjetter på at det gir mening å kombinere med CPI.

1 Like
#36

https://www.astrazeneca.com/media-centre/press-releases/2021/imfinzi-and-tremelimumab-showed-survival-in-poseidon.html

2 Likes
#37

https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(21)00097-8/fulltext

Ipilimumab alone or ipilimumab plus anti-PD-1 therapy in patients with metastatic melanoma resistant to anti-PD-(L)1 monotherapy: a multicentre, retrospective, cohort study

In patients who are resistant to anti-PD-(L)1, ipilimumab plus anti-PD-1 seemed to yield higher efficacy than ipilimumab with a higher objective response rate, longer progression-free, and longer overall survival, with a similar rate of grade 3–5 toxicity. Ipilimumab plus anti-PD-1 should be favoured over ipilimumab alone as a second-line immunotherapy for these patients with advanced melanoma.

2 Likes
#38
#39

Dette har jeg lurt veldig på og nå begynner det å komme litt forskning rundt temaet. Viktig for pasienter med autoimmune sykdommer.

#40

Veldig interessant link til en Trending list av pub med-artikler. Hold deg oppdatert på det som foregår i verden.

1 Like
#41

De første Keytrudaresultatene på ASCO var ikke så mye å rope hurra for

1 Like
#42
4 Likes