Biotech Strategy Blog

Commentary on Science, Innovation & New Products with a focus on Oncology, Hematology & Cancer Immunotherapy

Posts tagged ‘ROCKET trial’

Dr Stephan Grupp at SITC17

National Harbor, MD – SITC 2017 wouldn’t be the same without an in-interview with Dr Stephan Grupp (CHOP) on the issues surrounding the Juno ROCKET trial and CAR T cell therapy safety.

This data has been eagerly awaited and anticipated by the field since the news of a cluster of lethal cerebral oedemas hit Juno in the summer 2016, seemingly out of the blue.

Yesterday, we reviewed the salient points from Dr Mark Gilbert (CMO) presentation highlighting their findings from the in-depth analyses performed to date.

In the second part we turn to a CAR T cell therapist with experience in treating children and young adults for his perspectives and candid reactions to the information presented.

We also talk about where the field is headed and some of the new developments we can look forward to hearing more about in the near to medium term future.

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We’re overdue a roundup and discussion on various key topics of interest to BSB readers, so here goes…

Today’s topics include an in-depth look at the impact of some negative events:

  • Kite and the cerebral oedema death with axi-cel
  • Genentech’s atezolizumab OS miss in urothelial cancer

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No CyclingLate this afternoon, Juno Therapeutics ($JUNO) announced (link to press release) that the FDA had put a clinical hold on enrollment into a phase 2 trial of their JCAR015 construct in relapsed refractory acute lymphoblastic leukaemia (ALL) in adults in the ROCKET Trial: NCT02535364.

The decision by the FDA was as a result of three recent patient deaths reported to be due to neurotoxicity. In after-hours trading the stock dropped 30% from a market close of $40.82, reaching an after hours low at time of writing of $26.66 at 4.43pm ET.

In this post we look at what happened, the possible reasons behind it, and what it may mean for other CAR T companies. A leading CAR-T cell expert also provided BSB with some commentary after the news broke.

Good News: Post now updated following FDA lifting hold on ROCKET trial.

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