Marker Therapeutics Inc (MRKR)

[Epicare]

Yescarta was approved after a six-month trial of 101 patients with an aggressive form of diffuse large B-cell lymphoma, a cancer that affects immune cells. This type of cancer affects roughly 30,000 Americans annually, and about two thirds of those patients can be cured with a regimen of cancer drugs. Yescarta is for those remaining 10,000 patients. In the recent trial, Yescarta cured 36% of patients completely, and in 82% of patients, their tumors shriveled down to less than half their original size.

CAR-T therapies are a possible treatment for patients who would otherwise be out of options, but they come with serious risks. STAT reports that in trials, Yescarta led over 40% of patients to develop anemia (low iron in the blood, essentially), and other common side effects included weakened immune systems from low white-blood cell counts. More worryingly, CAR-T therapy can set off a severe inflammatory reaction that can be fatal without additional immunosuppressive drugs. Two patients in this trial also died of severe brain damage associated with the drug. Similar side effects have been seen with the first FDA-approved CAR-T therapy.

https://qz.com/1106232/the-fda-approved-a-second-type-of-car-t-therapy-this-time-for-adults-with-a-form-of-lymphoma/

In the two-year analysis (n=108), Grade 3 or higher CRS and neurologic events were seen in 11 percent and 32 percent of patients, respectively, and were generally reversible. Four patients developed new serious adverse events (occurring since the previous August 11, 2017 data cutoff), none of which were related to Yescarta. No new Yescarta-related CRS or neurologic events or deaths have occurred since the one-year analysis.

https://www.marketwatch.com/press-release/kite-announces-two-year-data-for-yescarta-axicabtagene-ciloleucel-in-patients-with-refractory-large-b-cell-lymphoma-2018-12-02