Genmab, Johnson and Johnson’s Trial of Darzalex in Solid Tumors is Cancelled

According to a story from Reuters, the Danish biotech company Genmab saw its share value drop by a quarter after Johnson & Johnson, which had partnered with the company to use one of its most well known cancer drugs in a new study, decided to jump ship from the venture. The study was aimed to test Genmab’s drug Darzalex, which is normally used to treat multiple myeloma, in combination with atezolizumab as a treatment for non-small cell lung cancer.
Darzalex is a common treatment option for multiple myeloma, a type of cancer that affects plasma cells. The drug was given breakthrough therapy status by the FDA for multiple myeloma in 2013 and was approved in 2015 for multiple myeloma patients who had tried at least three other treatments. This indication was steadily expanded the following year and most recently in 2018. Darzalex has also been given orphan drug status for the treatment of other types of cancer, such as mantle cell lymphoma. It was approved by the European Medicines Agency (EMA) in 2016. The goal of the study was to measure the effectiveness of Darzalex against solid tumors.

Financial analysts projected that the outcome of the study would be the largest price trigger for the company’s stock. Considering the major drop that occurred after this announcement, it appears that they were correct. Johnson & Johnson decided to cancel the study for a couple of reasons:

  • First, a data monitoring committee submitted a review that indicated that the drug had failed to provide any observable benefit for non-small cell lung cancer patients.
  • Secondly, and perhaps more worryingly, the committee’s report stated that there was a marked increase in “mortality-related events.” This suggests that not only was Darzalex not effective in treating the cancer, but it was actually potentially causing harm to the patients.

While the cancellation is a major blow for Genmab, the CEO of the company, Jan van de Winkel, said that he fully stands by the decision.

“patient safety is paramount in drug development.” – Jan van de winkel

Jan is right; when a drug is causing harm to patients, that is definitely grounds for the cancellation of trials, especially when this harm appears before the study has fully begun.

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