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Array Biopharma Outlines Path To Market For New Myeloma Drug

Matthew Herper
Former Staff
I cover science and medicine, and believe this is biology's century.
This article is more than 10 years old.

This morning, Array Biopharma will outline its plans to investors to get its first wholly-owned drug, a treatment for the blood cancer multiple myeloma, approved by the Food and Drug Administration.

Codenamed ARRY-520, the medicine is a exciting because it is a new class of medicine, completely different from the immunomodulatory agents, including thalidomide, Revlimid, and Pomalyst, all made by Celgene , and the proteasome inhibitors Velcade, sold by Takeda, and Kyprolis, from Amgen . "In patients that have failed everything we believe 520 can offer benefit," says Ron Squarer, Array's chief executive.

In an mid-stage study of patients who had failed other drugs, 16% of patients saw the amount of cancer in their blood decrease after receiving ARRY-520 (this is known as the objective response rate, or ORR). In patients who had low levels of a protein that is a marker for inflammation known as AAG, the ORR jumped to 23%.

Here's the plan, as described to me by  Squarer and Array senior vice president Andrew Robbins:

  1.  Array plans to start a phase III trial that will compare the combination of ARRY-520 and Kyprolis to Kyprolis alone in patients who have myeloma that has relapsed and is refractory to other treatments and who have low levels of AAG. Interestingly, Kyprolis isn't actually fully approved, and it's approval could be revoked, but experts say that is unlikely. “I cannot imagine a scenario where the phase III for [Kyprolis] is not positive,” says Sagar Lonial, a professor and hematologist at Winship Cancer Institute of Emory University.The primary endpoint, or main goal, of this study will be progression-free survival (the time until the cancer recurs) with objective response rate and survival as secondary endpoints. It's possible that an interim analysis could be added to allow for an accelerated approval. The exact size of the study is undecided.
  2. In order to prepare for this study, Array will first start a 75-patient trial in 75 patients is to provide “pharmacokinetic” data. It will not have to complete for the phase III to start.
  3. Array will also conduct a single-arm (no control group) study of ARRY-520 in patients who have failed Kyprolis. This study will not include dexamethasone, a drug that is commonly given to myeloma patients, under the logic that it might add side effects and cloud the results. The exact size of this study is also undecided.

Compared to other myeloma drugs, ARRY-520's side effects appear mild so far; it does not cause nerve damage, for instance. But it does result in drops in blood cell counts; Array say that so far, these have not resulted in serious symptoms for patients.

Lonial, the hematologist, is a paid consultant to Array. He says that he has seen responses in patients who have failed Revlimid, Velcade, and Kyprolis. “We have people who drive a long ways to come here to get the drug.” More data on ARRY-520 is likely to be presented at the annual meeting of the American Society of Hematology later this year.

Matthew Herper
Matthew Herper