Novartis Reports Updated Results From Kymriah's JULIET Study

Novartis AG (NYSE:NVS) announced updated results from the pivotal JULIET study. It showed sustained complete responses at six months with Kymriah suspension for intravenous infusion, in adult patients with a difficult-to-treat cancer- relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL).

Kymriah (tisagenlecleucel), formerly CTL019, is the first chimeric antigen receptor T cell (CAR-T) therapy approved. The drug has been developed in collaboration with the University of Pennsylvania. This novel immunocellular therapy and one-time treatment uses patient's T cells to fight cancer.

CAR T therapies are developed for individual patients using their own cells, thereby making it different from typical small molecule or biologic therapies.

So far this year, Novartis’ shares have gained 15.2%, compared with the industry’s growth of 15.6%.

JULIET is the first multi-center global registration study for Kymriah in adult patients with r/r DLBCL and the second global CAR-T cell therapy trial. In the study at six months, 30% of patients treated with Kymriah showed complete response. The relapse-free probability at six months after first response was 74%. Median overall survival was not achieved and the median time from infusion to data cutoff was 5.6 months.

When the patients with DLBCL enrolled for this study, they had to go through multiple rounds of chemotherapy and many had unsuccessful stem cell transplants, leaving them with few options and a poor prognosis. The study showed that Kymriah was able to considerably increase their chance of achieving and maintaining a sustained response without stem cell transplant, thus highlighting its benefit.

Additionally, the study revealed that cytokine release syndrome (CRS) occurred in 58% of the total patients under treatment while 23% experienced grade 3/4 CRS (15% grade 3; 8% grade 4) using the Penn Grading Scale. Also, it showed that 21% of patients experienced any grade neurologic events and 12% of patients had grade 3/4 neurologic adverse events, who were provided supportive care.

In the study, 26 patients (26%) were infused in the outpatient setting of which 20 patients (77%) remained outpatient for three or more days after infusion.43 patients discontinued before infusiondue to rapid progression of their disease or deterioration in their clinical status.

According to the study, only nine out of 147 (6.1%) enrolled patients could not be infused due to inability to manufacture an adequate dose of CAR-T cells.

Novartis submitted a supplemental Biologics License Application (sBLA) to the FDA in October for Kymriah suspension for intravenous infusion. The applicationwas filed for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant (ASCT).

Again in November, the company submitted an application to the European Medicines Agency (EMA) for Kymriah for the treatment of adult patients with r/r DLBCL who are ineligible for ASCT and for children as well as young adults with r/r B-cell ALL.

Of late, Gilead (NASDAQ:GILD) also received FDA approval for Yescarta — a CAR-T therapy for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. Yescarta is the first CAR-T therapy approved by the FDA for this indication.

Another company, bluebird bio, Inc.’s (NASDAQ:BLUE) anti-BCMA CAR T therapy, bb21217, is being evaluated for relapsed/refractory multiple myeloma. bb21217 as well as bb2121 are being developed in collaboration with Celgene (NASDAQ:CELG) .

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