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Living Drugs For Cancer - ASH Update

Yescarta Kymriah 121217

Treatment for cancer patients has undergone a sea change over the past few decades and is still evolving. A brand new therapy for treating cancer to have reached the market is chimeric antigen receptor T-cell (CAR T) therapy, which scientists refer to as a 'living drug'.

The CAR T-cell therapy is a form of immunotherapy in which a patient's immune cells called T cells are collected, and genetically reengineered in the lab to produce more receptors on their surface so that the T cells can better detect and kill the cancer cells. The reengineered T cells, known as "chimeric antigen receptor (CAR) T cells", are multiplied in the laboratory and then infused into the patient's blood.

The first living drug to get the FDA blessing is Novartis' (NVS) Kymriah, which was approved in August of this year for the treatment of children and young adults up to 25 years of age suffering from a form of acute lymphoblastic leukemia that doesn't respond to standard treatment or has relapsed at least twice.

Looking to expand the use of its CAR T-cell therapy in additional indications, Novartis has been testing Kymriah in the indication of difficult to treat diffuse large B-cell lymphoma (r/r DLBCL) in adults who have received at least 2 lines of chemotherapy.

According to the updated data from a pivotal trial of Kymriah in adults with r/r DLBCL, dubbed JULIET, presented at the ASH, 53% of patients responded to therapy (best overall response rate), with 40% patients having complete response (CR) and 14% achieving a partial response (PR) among 81 infused patients with three or more months of follow-up or earlier discontinuation.

At six months, the overall response rate with Kymriah was 37%, complete response rate was 30%, with a 74% relapse-free rate after onset of response.

Novartis' Kymriah is not the only CAR T-cell therapy to have secured the FDA approval. There is yet another 'living drug' - Kite/Gilead's (GILD) Yescarta.

Yescarta received the FDA nod in October of this year for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma (transformed follicular lymphoma, or TFL).

So how did Yescarta fare in the DLBCL population? Note, that Yescarta is approved for DLBCL.

In the phase II trial, dubbed ZUMA-1, Yescarta, at 3 months demonstrated an ORR of 39% and complete response of 33% while at 6 months the ORR was 36% and CR was 31% in the DLBCL patients.

The ZUMA trial has enrolled patients with DLBCL, primary mediastinal large B cell lymphoma or transformed follicular lymphoma.

Novartis' ORR and CR data for Kymriah at 6 months is almost on par with Kite/Gilead's Yescarta.

Novartis has already submitted a supplemental Biologics License Application to the FDA seeking approval for Kymriah in adult patients with r/r DLBCL. Going by the data, FDA approval for the expanded indication looks like a sure thing.

Novartis has sought approval of Kymriah for treating the two forms of blood cancer in Europe too.

Kite/Gilead also presented new data from the ZUMA-1 trial at the ASH.

According to the updated analysis, at a median follow-up of 15.4 months after a single infusion of Yescarta, 42% of patients remained in response, including 40% in complete remission. The overall median duration of response is 11.1 months and overall survival rate at 18 months is 52%.

Like Novartis, Gilead's subsidiary Kite is also testing its CAR T-cell therapy Yescarta for a second indication - for the treatment of adult patients with relapsed or refractory acute lymphoblastic leukemia, and is in a phase I/2 study, dubbed ZUMA-3.

In the ZUMA-3 study, at eight weeks of follow-up, 71% of acute lymphoblastic leukemia patients achieved complete remission, with 100% of responders having no detectable minimal residual disease, including in those with high tumor burden and high risk genetic abnormalities.

In the U.S, Novartis' Kymriah costs $475,000 (list price) while Gilead's Yescarta is priced at $373,000. Both the therapies are given as a one-time treatment.

The approval of the two CAR T-cell therapies herald a new era in the treatment of cancer, and is being widely talked about. But what is also being extensively discussed is their hefty price tag.

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