CD19 CAR-T Cell Therapy! Novarma Kymriah Treatment of Recurrence or Refractic Foly Lymphoma (FL): Total remission rate 83%!

December 06, 2020 // -- Novartis recently released the analysis of two independent trials of CD19 CAR-T cell therapy Kymriah (tisagenlecleucel) in patients with advanced lymphoma at the 62nd annual meeting of the American Society of Hematology (ASH).
the first analysis came from an interim analysis from the Phase II ELARA study, which was conducted in patients with recurring or refractive folytic lymphoma (r/r FL) who had previously received multiple therapies (median: 4 (range: 2-13).
data show that after at least three months of follow-up, Kymriah's treatment had a total remission rate (CR) of 65% and a total remission rate (ORR) of 83%.
second analysis came from a 40-month follow-up analysis in the Phase II JULIET study, which was conducted in patients with relapsed or refratic large B-cell lymphoma (r/r DLBCL).
, Kymriah's two-year progress-free survival (PFS) rate was 33 per cent.
this analysis is an important finding, given the limited treatment options available for lasting relief in these patients.
analysis reaffirmed Kymriah's security and found no new short- or long-term security signals.
Kymriah is the first CAR-T cell therapy approved by the FDA and the first car-T cell therapy approved for two different adaptive disorders.
the drug is a one-off treatment designed to boost a patient's immune system against cancer.
Currently, Kymriah's approved adaptations include: (1) treatment of recurring or recurring acute lymphoblastic leukemia (R/R ALL) and young adult patients (age 25 years old) ;(2) treatment of recurring or resuscable large B-cell lymphoma (R/R DLBCL) adult patients.
, based on preliminary results from the ELARA trial, the FDA granted Kymriah treatment R/R FL Advanced Therapy for Regenerative Medicine (RMAT), reflecting significant unsequal medical needs in the R/R FL patient population.
has plans to file a regulatory application for Kymriah Treatment R/R FL in the United States and later in the European Union in 2021.
if approved, R/R FL will be Kymriah's third B-cell malignant tumor adaptation.
Mr. John Tsai, Novart's global head of drug development and chief medical officer, said, "Novardo is committed to continuing to explore the safety and effectiveness of Kymriah for patients with advanced blood cancer who have not been able to achieve long-term remission despite previous multiple treatments.
as we go deeper into CAR-T cell therapy, these new analyses demonstrate Kymriah's potential to rewrite cancer survival rates in some patients with advanced lymphoma.
" Photo Source: childrenshospital.org-ELARA Study Interim Analysis: 52 patients with assessable efficacy, median follow-up time of 9.9 months, Kymriah for most of the patients treated.
specifically, 65% (99.5% CI: 45.1-82.4) of patients who followed at least three months of follow-up received complete remission (CR), reaching the primary endpoint.
mitigation rate (ORR) was 83% (95% CI: 69.7-91.8).
for patients with complete remission, the vast majority (90%) of patients ≥ for six months.
safety results showed that no new safety signals for Kymriah appeared in the 97 patients who were assessed for safety.
49% of patients developed cytokine release syndrome (CRS, 29% for level 1 and 20% for level 2) and no patients developed grade 3/4 CRS.
treatment of CRS, 15 per cent of patients were treated with tocilizumab and 3 per cent were treated with steroids.
neural events (NE) in 9% of patients and 3/4 NE in 1% of patients.
4 days for CRS and 8.5 days for severe NE, and 4 days for resolution and 2 days, respectively.
ALL NE and CRS are resolved through appropriate measures.
3 patients died from ongoing diseases and no treatment related deaths.
in the ELARA study, 18 percent of patients received Kymriah treatment at the clinic.
40-month follow-up analysis in the U.S.-JULIET study: Patients treated with Kymriah (n-115) showed sustained and lasting remission.
of the 61 patients treated with remission, the probability of recurrence was 60% for 24 and 36 months, and the medium duration of remission (DOR) had not yet been reached (95% CI:10-NE).
survival rate of 33 per cent for two years.
40 per cent and 36 per cent, respectively, for 24 and 36 months.
, after more than three years of long follow-up observation, no new safety signals were found.
the study, the researchers also assessed the relationship between biomarkers such as baseline Myc over-expression in tumors and tumor micro-environments (TME) and Kymriah therapeutic responses.
analysis showed that Myc had a better prognosis than patients who over-expressed Myc.
Myc over-expression can lead to poor immunosuppressive TME and limited T-cell response.
these results are consistent with the historical results of Myc-and-Myc-expression patients.
to further determine the car-T cell therapy response is under way.
the original source: Novartis analyses confirm benefit of Kymriah? with clinically meaningful rates of complete response in patients with certain advanced lymphomas