China’s drug regulator granted a first CAR T therapy approval to Fosun Kite Biotechnology’s FKC-876. Marketed as Yescarta (axicabtagene ciloleucel) in the US and EU, the approval by the National Medical Production Administration for the CD19-directed CAR T therapy came 3.5 years after the FDA nod.
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China granted first CAR T approval to Fosun-Kite’s Yescarta
With a tentative brand name Ejilunsai in China, the CAR T therapy will be indicated for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma and DLBCL arising from follicular lymphoma.
CLINICAL
BMS CAR T outperforms stem cell transplant in lymphoma
BMS released top-line Phase 3 results from its CAR T therapy Breyanzi (lisocabtagene maraleucel) that could support its use earlier in patients with refractory large B-cell lymphoma, outperforming standard stem cell transplant therapy. Though no new safety signals emerged, as with other CAR Ts, patients must be constantly monitored for CRS and neurological toxicities, adding to treatment costs beyond the hefty price tags commanded by CAR Ts so far.
Allogene’s CAR T therapy in large B-cell lymphoma demonstrates efficacy signals
ALLO-501A, an allogeneic CAR T-cell product, plus ALLO-647 lymphodepletion as therapy for patients with relapsed/refractory large B-cell lymphoma (LBCL) who did not previously receive autologous CAR T-cell therapy elicited encouraging signals of clinical activity in Phase 1/2 ALPHA2. Data showed that the ORR with ALLO-501A in all patients (n = 9) was 56%, which included a 44% CR rate. Specifically, in those who received ALLO-501A at the second dose level of 120 x 106 CAR T cells (n = 4), the ORR was 50% and both responses were CRs. For those who received ALLO-501A as a consolidation treatment (n = 5), the ORR was 60% and the CR rate was 40%.
Kite’s Yescarta shows positive results in second-line lymphoma study
Gilead company Kite has unveiled positive results for its CAR-T therapy Yescarta in the second-line setting for relapsed or refractory large B-cell lymphoma. The top-line results come from the Phase 3 ZUMA-7 trial, which is investigating Yescarta (axicabtagene ciloleucel) compared to SOC in second-line LBCL. In relapsed or refractory LBCL, SOC includes the reintroduction of an immunochemotherapy followed by high-dose chemotherapy plus stem cell transplant if the patient responds and can tolerate further treatment. After a median follow-up of two years, Yescarta showed a 60.2% improvement in event-free survival (EFS) compared to SOC. EFS was defined in the study as the time from randomisation to disease progression, the start of a new lymphoma therapy or death from any cause. The trial also met the secondary endpoint of ORR, with investigators also noting that overall survival showed a trend favouring Yescarta at the time of the interim analysis.
CAR T-Cell therapy trial in solid tumors halted following two patient deaths
Tmunity Therapeutics has halted the development of its lead CAR T-cell product following the deaths of 2 patients who were enrolled to a trial investigating its use in solid tumors. The patients reportedly died from immune effector cell-associated neurotoxicity syndrome (ICANS), which is a known adverse effect associated with CAR T-cell therapies. The company is dedicated to the development of novel approaches that produce best-in-class control over T-cell activation and direction in the body.
REGULATORY
Novartis to file CAR T Kymriah in follicular lymphoma after Phase 2 readout
Novartis’ Kymriah (tisagenlecleucel) is heading for a third indication after the pharma announced supportive results from a pivotal Phase 2 trial, lining it up to compete with Gilead’s rival Yescarta. Novartis plans global filings in this third indication, which could add to Kymriah’s traction after a fairly slow start after its first approval in 2017.
Autolus announced ILAP designation for obe-cel for treatment of relapsed/refractory adult B-cell ALL
Autolus announced that it has received innovative licensing and access pathway (ILAP) designation from UK MHRA for AUTO1 (obe-cel), the company's CAR T cell therapy being investigated in the ongoing FELIX Phase 1b/2 study in relapsed / refractory adult B-cell ALL in patients 18 years and older. The ILAP designation for obe-cel, alongside the PRIME designation from EMA, is another step forward in accelerating the review process of this promising therapy.
