Upcoming Webinars Archived Webinars Training Vitals Host A Webinar About Get Updates Contact

Update: Juno’s CAR-T Clinical Trial To Resume After FDA Rescinds Clinical Hold

XTALKS VITALS NEWS

FDA

Juno has revised the treatment protocol for the study – named “ROCKET” – to stop using the chemotherapy drug, fludarabine, which was implicated in the patient deaths.

Tweetables from this article:

Tweet: #FDA has lifted the clinical hold on study of Juno Therapeutics’ CAR-T therapy http://ctt.ec/_4XQC+FDA has lifted the clinical hold on study of Juno Therapeutics’ CAR-T therapy.

Tweet: Juno will now exclusively use the cancer drug, cyclophosphamide, before CAR-T http://ctt.ec/cL6r7+Juno will now exclusively use the cancer drug, cyclophosphamide, before CAR-T.

Share this!

July 14, 2016 | by Sarah Massey, M.Sc.

The US Food and Drug Administration (FDA) has lifted the clinical hold on a study of Juno Therapeutics’ lead CAR-T therapy, which will allow the biotech company to resume enrollment. The Phase II clinical trial was put on hold last week following the deaths of three patients receiving the immunotherapy.

Juno has revised the treatment protocol for the study – named “ROCKET” – to stop using the chemotherapy drug, fludarabine, which was implicated in the patient deaths. To pre-condition patients before they receive the CAR-T cell therapy, the study investigators will now exclusively use the cancer drug, cyclophosphamide.

Alongside Kite Pharma and Novartis, Juno has been a leader in the promising CAR-T therapy space. After three patients died following treatment with the company’s lead candidate – known as JCAR015 – many raised concerns about the cancer treatment’s safety.

JCAR015 was designed to treat patients with relapsed or refractory B cell acute lymphoblastic leukemia. The FDA’s clinical hold on the study was expected to be a major roadblock delaying, or even preventing, further development of JCAR015.

As Juno was quick to identify fludarabine as the likely culprit in the patient deaths, the FDA has given the company the go-ahead to continuing enrolling more patients in the clinical trial. Despite the quick turn-around, the delay could still affect Juno’s plans to apply for FDA approval in 2017.

“Our view is not that this toxicity was caused exclusively by this second chemotherapy called fludarabine that we added,” said Juno CEO Hans Bishop, on CNBC. “It is a combination of the strength of the chemotherapy we used with the cells.”



Last week, Juno submitted revised copies of its consent form, investigator brochure and trial protocol to the FDA, complying with the regulator’s request for this information. While the FDA has approved Juno’s request to continue with the ROCKET clinical trial, it’s still not certain how fludarabine – in combination with the CAR-T immunotherapy – led to the death of the three patients.

Juno conducted a previous CAR-T clinical trial using cyclophosphamide alone, and received positive results from that study. According to Bishop, JCAR015 still has the potential to be an effective treatment for patients with relapsed or refractory B cell acute lymphoblastic leukemia.

“Losing patients on a clinical trial is always more than a blip in the road. It is a sobering experience,” continued Bishop. “We are clearly figuring out how to best use these potent therapies. The promise of them, I think remains unchanged.”


Keywords: CAR-T, FDA, Clinical Trial


| NEXT ARTICLE | MORE NEWS | BLOGS | VIDEOS | POLLS & QUIZZES | WEBINARS |

Share this with your colleagues!

MORE NEWS
Lavazza Acquires Controlling Stake in Canada’s Kicking Horse Coffee

May 26, 2017 - Italian coffee company Lavazza, has secured an 80 percent equity stake in Canadian organic and fair-trade coffee company Kicking Horse Coffee, in a deal worth CAD$215 million.

Featured In: Food News


FDA First: Keytruda Approved for Cancer Treatment Based on Biomarker Alone

May 25, 2017 - For the first time, the FDA has approved a cancer treatment for solid tumors based on the presence of a biomarker, as opposed to specifying a tissue of origin.

Featured In: Biotech News


One Year of Medically Assisted Dying in Canada

May 25, 2017 - In June of 2016, the federal government of Canada passed legislation to legalize medically assisted dying.

Featured In: Life Science News


LEAVE A COMMENT
 
  
THE XTALKS VITALS INDUSTRY BLOG

Top 5 Most Impactful Tweets in Life Sciences During the Last Week

REGISTER FOR THESE WEBINARS

EU IVD Regulation: Top Five Changes for Medical Device Manufacturers to Consider


Thermal Processing Systems for the Food Industry: A Guide to Selecting Thermal Equipment and Technology


Rare Disease & Orphan Drug Development: Cost-Efficient Trial Design to Minimize Cash Burn


eTMF Workflows: Active eTMF to Improve the Quality of Clinical Trials


Copyright © 2016-2017 Honeycomb Worldwide Inc.