Juno was stopped in key clinical trials in car-t accident

Source: Sino American Pharmaceutical Co., Ltd July 8, 2016, Juno, the main competitor of car-t therapy, announced that the second phase clinical trial of car-t therapy jcar015 was stopped by FDA due to the death of patients This is a phase II clinical recruitment of more than 20 adult rrall patients Although 80% of the responses were generated, three brain edema deaths occurred successively According to Juno, all the dead patients had used the chemotherapy drug fludarabine before car-t Neurotoxicity is a known side effect of car-t, but there was no event of death Cyclophosphamide is also used in car-t preparation, but not as toxic as fludarabine Jcar015 was expected to be Juno's first car-t drug on the market Now, it is almost impossible to realize its 2017 marketing plan Juno shares plummeted 30% immediately after the announcement, while its main competitor, kite shares, also fell 10% on the back of a gun This is Juno's second clinical trial to be terminated because of the patient's death In 2014, two patients in another car-t clinical trial of Juno were stopped due to cytokine storm death, but recovered soon Juno will submit relevant documents to FDA next week The general review time is one month, but the clinical trial may not be resumed in one month Zafgen's weight-loss drug, which was stopped last year because of two deaths from pulmonary embolism, has not yet resumed clinical trials Car-t has become one of the most attractive therapies for cancer drugs because of its high response rate in advanced blood tumors 90% of patients with advanced rrall have a high response rate These patients were 100% dead a few years ago, and now car-t and another kind of bite antibody against CD19 have greatly increased their chances of survival Emma Whitehead, the first child leukemia patient to use car-t, was dying at that time, and she is still healthy for four years after using car-t The reason why fludarabine was used was that the use of this cytotoxic drug in advance significantly improved the efficacy of car-t and delayed recurrence Car-t therapy is effective but also has considerable risks Early cytokine toxicity can be better controlled due to the accidental discovery of the detoxification effect of IL6 antibody, but we do not know how to predict and control the toxicity today Compared with common drugs, it is relatively difficult to import these more aggressive T cells to produce toxic reversion, so bite antibodies such as blinatumomab are more advantageous in controlling toxic and negative reactions The production, quality control and price of car-t are also unfavorable factors for competition But car-t is still a kind of subversive therapy Today's car accident doesn't mean that the development of this therapy will stop The cost of exploring unknown areas may sometimes be the loss of life But as President Reagan said on the day of the Challenger crash, these sacrifices are part of scientific exploration, aviation will continue, and the future belongs to the brave The R & D of car-t will continue, and the final listing is almost certain.