Hva er forskjellen fra chronos 3 til chronos 4 her .NCT02626455
1 Like
Chronos-3 er i kombinasjon med rituximab.
Chronos-4 er kombi med både rituximab og kjemoterapi…
Uansett mener jeg å henge seg opp i copanlisib er et lite blindspor…
Betalutin er et helt annerledes legemiddel som har en helt annen virkemåte og angrepspunkt mot kreften, samtidig som det møter mange kriterier copanlisib ikke oppfyller (ift Qol og oppregulering cd-20 spesielt…)
FDA kommer til å se at det er behov for betalutin også innen denne indikasjonen så fort man har sterk nok dokumentasjon - og da spesielt fordi enkelte kun kan tåle bivirkninger som er milde og kortvarige, men også helhetsbildet av medisinen (effekt, oppreg cd20, synergier, abscopal effekt) tilsier det - det er ihv min overbevisning…
11 Likes
Takk meget bra forklart
Betyr det at chronos 3 blir ikke ferdig for i 2023.Føler uansett vi har god tid å få midlertidig godkjent Paradigme
ref Drug: Copanlisib (BAY 80-6946.Estimated Study Completion Date : January 13, 2023
2 Likes
På bakrun av dette fikk Copanlisib akselert godkjent
The FDA has granted an accelerated approval to copanlisib (Aliqopa) as a treatment for patients with relapsed follicular lymphoma who have received at least 2 least prior systemic therapies.
The approval of copanlisib is based primarily on findings from the phase II CHRONOS-1 trial, which included patients with multiple types of lymphoma. In the study, 59% of patients achieved objective responses to the intravenous inhibitor of PI3K-alpha and delta. Responses were durable, and the median progression-free survival (PFS) approached 1 year.
“For patients with relapsed follicular lymphoma, the cancer often comes back even after multiple treatments,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a statement. “Options are limited for these patients and today’s approval provides an additional choice for treatment, filling an unmet need for them.”
Copanlisib is an intravenous pan-class I PI3K inhibitor that has predominant activity against the PI3K-alpha and delta isoforms. The alpha isoform is broadly expressed and involved in insulin signaling and angiogenesis, as well as resistance mechanisms to lymphoma. The delta isoform is expressed by leukocytes and is involved in B-cell signaling, development, and survival.
Lymphoma subtypes included in the CHRONOS-1 study were follicular lymphoma (grades 1-3a), marginal zone lymphoma, small lymphocytic lymphoma, and lymphoplasmacytic lymphoma (LHL)/Waldenstrom macroglobulinemia (WM). Eligible patients had relapsed or refractory disease and failure of at least 2 prior lines of therapy.
Patients received copanlisib at 60 mg on days 1, 8, and 15, repeated every 28 days until disease progression or development of unacceptable toxicity. The primary endpoint was objective response by central review after a minimum of 16 weeks of treatment. Secondary endpoints included PFS, duration of response, overall survival, safety, and quality of life.
Data analysis included 142 patients who had a median age of 63. The median time since the most recent disease progression was 8.3 months, and the study population had received a median of 3 prior regimens. All of the patients had prior exposure to rituximab (Rituxan) and 1 or more alkylating agents, and 60.6% had disease that was refractory to the last regimen received.
Across the lymphoma subgroups, 80.3% of the patients had advanced disease (stage III or IV) at enrollment. Follicular lymphoma was the dominant lymphoma subtype, accounting for 73.2% of the study population.
Patients remained on treatment for a median duration of 22 weeks, during which time they received a median of 5.5 cycles of therapy and 96% of planned copanlisib doses.
All but a few patients had some degree of target lesion shrinkage in response to treatment with copanlisib. Patients with all lymphoma subtypes had lesion shrinkage.
The 59.2% overall response rate included complete responses in 12.0% of patients and partial responses in 47.2% of patients. An additional 29.6% of patients had stable disease, resulting in a disease control rate of 85.9%. Objective response rates were 59% or higher across all lymphoma subtypes except LHL/WM, wherein 1 of 6 patients with the subtype achieved an objective response with copanlisib.
The study population had a median PFS of 11.2 months (95% CI, 8.1-24.2). In the follicular lymphoma subgroup, the median PFS was also 11.2 months.
The most common adverse events (all grades) were hyperglycemia (48.6%), hypertension (28.9%), and decreased neutrophil count (24.6%). Grade 3 hyperglycemia occurred in 33.1% of patients and grade 4 in 7.0%. Grade 3 hypertension occurred in 22.5%. Grade 3 decreased neutrophil count occurred in 6.3% and grade 4 in 12.7% of the patients. The most common laboratory abnormalities were elevated liver enzymes, which was grade 1/2 in all but a few cases.
The accelerated approval of copanlisib is contingent upon the results of a confirmatory trial.
Dreyling M, Santoro A, Mollica L, et al. Copanlisib in patients with relapsed or refractory indolent B-cell lymphoma: primary results of the pivotal CHRONOS-1 study. Presented at: 2017 AACR Annual Meeting; April 1-5, 2017; San Washington, DC. Abstract CT149.
1 Like
COPANLISIB TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA
Results: The 23 MZL patients enrolled included 15 (65%) nodal MZL and 4 each (17%) with mucosa‐associated lymphoid tissue (MALT) lymphoma and splenic MZL.
Objective responses by independent assessment were observed in 18 patients (ORR 78%) and CRs in 3 patients (13%);
ORRs were 50% (2/4 patients) in MALT MZL, 87% (13/15 patients) in nodal MZL and 75% (3/4 patients) in splenic MZL.
Kontra Betalutin´s resultater for Marginal zone lymphoma : ORR 78% og CR: 44%
Data for - Mantle Cell Lymphoma, MZL pasienter
PR: 33%
CR: 44%
SD: 22%
PD: 0
ORR = CR + PR = 77%
DCR= CR + PR + SD eller ORR + SD= 99% eller 100%
CR: complete response: Complete response doesn’t necessarily mean that you are cured, but it is the best result that can be reported. It means the cancerous tumor is now gone and there is no evidence of disease.
PR: partial response: A partial response is most often defined as at least a 50% reduction in measurable tumor. Here, when we refer to a remission it will generally mean a partial remission
ORR: objective response rate: When used as a clinical endpoint for clinical trials of cancer treatments, this often called the objective response rate (ORR). The FDA definition of ORR is "the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period
SD: stable disease: being a little better than progressive disease, which means that a tumor has increased in size by at least 20 percent, and a little worse than a partial response, which means that a tumor has decreased in size by at least 50 percent
DCR: disease control rate
ORR = CR + PR
DCR= CR + PR + SD eller ORR + SD
Bayer med sin 13% CR kan ikke behandle pasienter som er i dårlig form i motsetning til Betalutin med sin 44% CR som er nesten harmløs. De fleste pasienter er eldre med dårlig helse. Pasienter er uten en god alternativ nå og de dør.Vi må heller ikke glemme at Copanlisib kan gi alvorlige bivirkninger.God Jul
Husk Skatteplanlegging og formueskatt tror det er siste dagen mandag de som har kjøpt til høyre kurs kan selge å realisere tapet .Tror vi ser mye omsetning av aksjer pga skatteplanlegging.
Se på denne bildet Copanlisib akselert godkjenning med CR 14% og ORR 59%
Enda verre me Duvelisib akselert godkjenning
Med CR 1% og ORR 42%!
Se gennemsnittet alderen på Nano pasienter 69 år uten alternative behandlinger som venter på å dø i tillegg Betalutin har omtrent ingen bivirkninger.Dette skal gå rette veien folkens.
Interessant info fra Finn. Har du erfaring fra produksjon av radiofarmaka?
Arbeidsgiver
Nordic Nanovector ASA
Stillingstittel
Radiofarmasøytisk ekspert
Frist
15.02.2021
Ansettelsesform
Fort
På vegne av Nordic Nanovector ASA leter vi etter en radiofarmasøytisk ekspert som vil være ansvarlig for utviklingen av medikamentproduktet Betalutin for bruk i kliniske studier, samt for å utvikle Betalutin-produksjonen for den kommersielle fasen. Stillingen er en mulighet til å bli med i et innovativt selskap i farmasøytisk industri som jobber mot nye og lovende kreftbehandlinger. Radiopharmaceutical Expert vil være en del av et mangfoldig, dedikert og høyt erfaren CMC-team.
Hovedansvarsområder
- Koordinere prosjektrelaterte aktiviteter for utvikling og produksjon av Betalutin
- Administrere / delta i all utvikling av kjemi, produksjon og kontroll (CMC) relatert til selskapets radiofarmasøytiske produkter, inkludert prosessutvikling, karakterisering og validering
- Tett tilsyn med CMOs og CROs ytelse for å sikre effektiv, god kvalitet og kostnadseffektiv tilførsel av Betalutin medisinprodukt globalt
- Utarbeidelse av originale protokoller, rapporter eller andre former for sammendragsbeskrivelser av relevant vitenskapelig og teknisk informasjon i tråd med instruksjoner og myndighetskrav
- Deltar i utviklingen og implementeringen av internasjonale CMC Regulatory strategier
- Ansvarlig for vitenskapelig utvikling for radiofarmasøytiske produkter i samsvar med selskapets strategi og prosjektplaner
- Ansvarlig for relevante CMC-seksjoner av IND, NDA, BLA, CTA, IMPD og MA for Betalutin og andre radiofarmasøytiske produkter under utvikling
- Oppfølging av gjeldende regelverk og krav i relevante områder, som Europa, USA og andre regioner
- Bidra til selskapets strategiske veikart for forskning og utvikling og aktiviteter til støtte for porteføljestrategien
- Lederteam for teknologioverføring til CMO og CRO når det er nødvendig.
- Server som CMC radiofarmasøytisk representant i teamet for teknisk utvikling
Jeg tolker spesielt dette som vi er på sporet av noe stort.
Stillingen er en mulighet til å bli med i et innovativt selskap i farmasøytisk industri som jobber mot nye og lovende kreftbehandlinger.
Snart AAA folkens H1 2022
24 Likes
Gjør seg kanskje bedre her.
Flere positive key takeaways:
-
Ser ut som bruken av 177Lu brer om seg til flere kreftformer, som er positivt mtp tilgang på råstoff, håndtering og logistikk.
-
Flere og flere prøver RIT/TAT i kombinasjon med CPI. Kanskje det vil skape interesse hos Merck, BMS, Roche og andre selskaper med CPI i produktporteføljen?
12 Likes
Indeed, consistent and repeated T cell stimulation may be achieved by RIT with its capacity to induce high numbers of CR, combined with rituximab maintenance capable of maintaining such CR. This approach may therefore be well suited as novel and readily feasible perspective towards potential cure of FL.
One could hypothesize that the patient’s T cell response would possibly be able to eradicate or at least control FL progenitor cells under such a combination of RIT with rituximab [103], a hypothesis supported by the observation of long-term CR after single agent rituximab and single agent RIT.
17 Likes
Store muligheter for Betalutin i MCL, en indikasjon som er større enn MZL
8 Likes
Mye bra info her for de som ønsker å lese seg opp på RIT
2 Likes
Måtte vel være i en eller annen form for kombinasjon da…?
Tror vel Betalutin som single agent i MCL ikke funker optimalt – ihvertfall om resultatene fra Lymrit er representative… (Er ikke helt vekke de resultatene, men 2 PD, 2 SD og en PR slik jeg leser det)
@InVivo: Nei, sjekka ikke linken før nå 
Den gav jo spekulasjonen litt mer kjøtt på beinet… 
Men altså, tror kanskje archer-løsningen kan funke bra her også for de som er i stand til å motta den – da får man angrepet kreften gjennom både cd-37 og cd-20 
4 Likes
Så du ikke linken? Er som konsolideringsterapi
1 Like
Gode muligheter for 1L?? 
Radioimmunotherapy as the first line of treatment in non-Hodgkin lymphoma
and discussed potential novel indications, and strategies such as modifying induction therapy and using rituximab maintenance to optimize the efficiency of RIT as the first line of treatment.
Our review indicates that it is more logical to postpone conventional therapies to the second or third lines of treatment instead of RIT.
https://www.futuremedicine.com/doi/abs/10.2217/imt-2017-0169
18 Likes
Jo før jo bedre! Husker også at Lisa Rojkjaer poengterte dette under en presentasjon
This long-lasting remissions may not be achieved if the administration of RIT is postponed to the second or third lines of treatment [30–32], as higher number of prior therapies is shown to be significantly associated with lower response rate and progression-free duration following RIT in NHL patients.
https://tekinvestor.no/t/nordic-nanovector-insidertrad-nanov/1451/1769?u=invivo
2 Likes
Smeller denne artikkelen inn her, drukner jo bare i støyen på småprat… 
Anbefalt lesning fore alle Nanonitter (og de som vurderer å bli det)
21 Likes
Takker for du deler! Den gikk ikke ubemerket i Småprat vil jeg påstå, hvordan kunne den med følgende closing “ Immunotherapy took the best part of 15 to 20 years to get going, ” reflected Mullen. “ Now nuclear medicine is the next immunotherapy. ”
3 Likes
400 MAUD up-front for en radiofarmaka deal i Kina! 
Isotopen er (selvsagt) Lu177 
Telix is pleased to partner with China Grand Pharmaceutical and Healthcare Holdings Limited in AU$400M strategic licence and commercial partnership for Telix’s portfolio of Molecularly-Targeted Radiation products in the Greater China market. Additionally, China Grand Pharma will make a strategic equity investment of AU$35M in Telix.
11 Likes
China Grand Pharma har jo vist tidligere at de har sansen for radiofarmaka etter oppkjøpet av Sirtex i 2018
Sirtex, an Australian biotech, specializes in the treatment of liver cancer with its lead product SIR-Spheres, which are radioactive beads that target high doses of radiation to liver tumors
6 Likes
Clinical trials oppdatert idag/igår:
8 Likes