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Novartis details results of next-gen CAR-T leukemia pilot

June 1, 2017

Switzerland-based Novartis (NVS) announced findings from a pilot study of CTL119 that had dazzling results.

CTL119 is a CAR-T cell therapy, where T cells that express chimeric antigen receptors (CAR) are engineered to target any cancer antigen desired. In the early study, nine patients with relapsed/refractory chronic lymphocytic leukemia (CLL) who had been on Imbruvica (ibrutinib) for at least six months, but were not in complete remission, had CTL119 added to their therapy regiment. In three months, eight of the nine patients showed no signs of CLL in their bone marrow. One of the patients had a partial response. There were a total of 10 patients in the study, but one did not produce data that could be evaluated.

“The data from this pilot study support the potential for CTL119, when combined with the kinase inhibitor ibrutinib, to induce clinically-significant responses in high-risk CLL patients who were unlikely to achieve a complete remission on ibrutinib alone,” said James Bradner, president of the Novartis Institute for Biomedical Research, in a statement. “CTL119 represents one of our latest advances in CAR-T cell therapy research and our broader commitment to pioneering breakthrough immuno-oncology treatments.”

John Carroll, writing for Endpoints News, says, “The work at Novartis reflects a commitment from all the lead players that the first wave of CAR-Ts—including KTE-CD19 (axicabtagene ciloleucel) from Kite Pharmaceuticals (KITE)—can be improved on with new technology. But it’s even more important for Novartis, which is out to demonstrate that it is completely committed to developing novel waves of CAR-Ts.”

Although the Novartis study had amazing results, it was not without the complications that have marked almost all CAR-T efforts. The small study had at least two serious cases of cytokine release syndrome (CRS). CRS is common with many monoclonal antibodies and is otherwise referred to as an infusion reaction. Per Breslin S in “Cytokine-release syndrome: overview and nursing implications,” “it results from the release of cytokines from cells targeted by the antibody as well as immune effector cells recruited to the area. When cytokines are released into the circulation, systemic symptoms such as fever, nausea, chills, hypotension, tachycardia, asthenia, headache, rash, scratchy throat, and dyspnea can result. In most patients, the symptoms are mild to moderate in severity and are managed easily. However, some patients may experience severe, life-threatening reactions that results from massive release of cytokines.”

These are sometimes referred to as “cytokine storms.”

Novartis indicated that all 10 patients in the study experienced CRS. Two of them were grade 3. However, no patients required treatment with Roche (RHHBY)’s Actemra, a drug that minimizes the response. All of the patients recovered from CRS. One patient also developed tumor lysis syndrome. Two patients had febrile neutropenia.

Saar Gill, an assistant professor of Hematology-Oncology at the Perelman School of Medicine and the Abramson Cancer Center of the University of Pennsylvania, will present the findings from the study at the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO) on Monday, June 5 at 1:15 PM CDT.

It was just reported yesterday that some investors are nervous about Novartis’s business plans. The company is considering selling off some of its largest assets, including U.S.-based eye care company Alcon (ACL). The total of the sales, if they came to fruition, would total about $50 billion, and some investors worry that Novartis will buy something large that won’t help the company as much as smaller deals.

One of the concerns about Novartis is that it’s lagging in the immuno-oncology market behind competitors Roche (RHHBY), Merck (MRK) and Bristol-Myers Squibb (BMY). However, if the company can get a successful CAR-T therapy to market, especially if it can beat Kite Pharmaceuticals (KITE), some of those concerns may be assuaged.

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