Missing in action at ASCO, ARRY-520 hot topic in Europe

Something was missing from this year’s American Society of Clinical Oncology (ASCO) meetings in Chicago this year.  Conspicuously absent was any news about one of the most promising anti-myeloma drugs, ARRY-520.  Why?  Was there a problem with ARRY-520′s trial data?

Absolutely not!  It turns-out that decision makers at the company that is developing ARRY-520, Array BioPharma Inc., had decided to delay announcing data until the European Hematology Association (EHA) meetings in Stockholm two weeks later.

Here’s the company’s official press release, summarizing ARRY-520 clinical trial data presented in Sweden:

Array BioPharma Announces Positive Interim Results From Combination Trial Of ARRY-520 With Kyprolis At The 2013 European Hematology Association Congress

By Array BioPharma

Published: Monday, Jun. 17, 2013

/PRNewswire/ — Array BioPharma Inc. (NASDAQ: ARRY) today announced that interim results from an ongoing ARRY-520 clinical trial in multiple myeloma (MM) were presented at the 2013 Congress of the European Hematology Association in Stockholm, Sweden. Also at the meeting, Array presented updated information on a potential patient selection marker for ARRY-520.  ARRY-520 is a highly selective, targeted inhibitor of KSP with a mechanism of action distinct from other drugs used to treat MM that continues to advance in clinical trials.

 

Phase 1 Study of the Novel KSP Inhibitor ARRY-520 + Carfilzomib in Patients with Relapsed and/or Refractory Multiple Myeloma (RRMM) (Protocol # ARRAY-520-112)

Interim data from an ongoing combination trial of ARRY-520 with Kyprolis® (carfilozomib) in patients with relapsed or refractory MM who are refractory or intolerant to Velcade® (bortezomib) were reported.  The combination has demonstrated early signals of activity with a disease control rate (complete response, partial response, minimal response or stable disease) of 82% and a clinical benefit rate (≥minimal response) of 53%, including one complete response.  In addition, the combination has been well tolerated with no unexpected hematologic toxicity and a manageable side effect profile.  More than half of the patients enrolled remain on study, with patients in the current cohort receiving full doses of both drugs without reaching a maximum tolerated dose (MTD).

“To date, the combination of ARRY-520 with Kyprolis has been well tolerated.  Reversible neutropenia is the most common adverse event and does not appear to be additive relative to the observed events for either drug alone,” said Jatin J. Shah, M.D., Assistant Professor, Lymphoma/Myeloma, Division of Cancer Medicine, The University of Texas, MD Anderson Cancer Center. ”While this is an ongoing study, and we await mature data, there have been promising signs of activity in a heavily pretreated population, which includes several patients previously exposed to ARRY-520 or carfilzomib.”

Alpha 1-Acid Glycoprotein (AAG) is a Potential Patient Selection Marker for Clinical Activity of ARRY-520 in Relapsed and Refractory Multiple Myeloma (MM) (Protocol # ARRAY-520-212)

Data on a potential patient selection marker was also presented from multiple studies of ARRY-520 in patients with relapsed and refractory multiple myeloma.  To date all responses have occurred in patients with low levels of alpha-1-acid glycoprotein (AAG) and these patients had longer event free survival (time to next treatment or death).  In a single-agent Phase 2 ARRY-520 clinical study, the median overall survival was reported to be markedly longer in patients with low AAG as compared to patients with high AAG (20.2 vs. 4.5 months). These results may enable more precise targeting of patient populations who will benefit from ARRY-520. 

About ARRY-520 for Multiple Myeloma

ARRY-520 is a highly selective, targeted inhibitor of KSP with a novel mechanism of action distinct from currently approved drugs to treat multiple myeloma (MM).  ARRY-520 preferentially acts on MM cells, versus terminally differentiated or epithelial cells, based on Mcl-1 survival dependence.  As predicted by its targeted mechanism, no treatment-related neuropathy and minimal non-hematologic adverse events, including gastro-intestinal and dermatological toxicities, have been reported with ARRY-520 therapy at the recommended dose.

ARRY-520 is currently advancing in three clinical trials.  Data from these three active trials will inform our pivotal trial decisions:

  • Phase 2 trial in combination with dexamethasone in patients with MM refractory to Revlimid® (lenalidomide), Velcade® (bortezomib) and dexamethasone therapy. 
  • Dose escalation trial in combination with Velcade® plus dexamethasone in patients with relapsed or refractory MM.
  • Investigator-sponsored dose escalation trial in combination with Kyprolis® (carfilzomib) in patients with relapsed or refractory MM who are refractory or intolerant to Velcade® therapy.

About Array BioPharma

Array BioPharma Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of targeted small molecule drugs to treat patients afflicted with cancer. Array is evolving into a late-stage development company and currently expects significant progress toward generating data to support our upcoming Phase 3 / pivotal trial decisions.   Novartis expects to begin Phase 3 trials evaluating Array-invented MEK162 in NRAS-mutant melanoma and in BRAF-mutant melanoma in 2013.  In addition, Array will begin a Phase 3 trial evaluating MEK162 in low-grade serous ovarian cancer under the license agreement with Novartis in 2013.  AstraZeneca began a pivotal trial with selumetinib (an Array-invented drug) in thyroid cancer in May 2013 and expects to begin a Phase 3 trial in non-small cell lung cancer during the second half of 2013.  Three other Array-invented drugs are also approaching Phase 3 or pivotal trial decisions which are expected by the end of 2013. These include Array’s wholly-owned drugs, ARRY-520 and ARRY-614, and one partnered program, danoprevir (with InterMune/Roche).  For more information on Array, please go to www.arraybiopharma.com.

These aren’t the only two ongoing ARRY-520 studies.  There is an ongoing Phase 2 study, focusing on ARRY-520′s activity as a single agent, and when its combined with granulocyte-colony stimulating factor (G-CSF) and/or dexamethasone:

http://clinicaltrials.gov/show/NCT00821249

along with a Stage 1 trial involving Velcade and dex:

 

http://clinicaltrials.gov/show/NCT01248923

There may be others, but these are the ones I’ve been following.  Early results look more promising than the immunotherapy, elotuzumab, and at least as promising as the new immunotherapy, daratumumab.

If your eyes are glazing over, I understand!  Just note that the great thing about all three of these drugs is that they aren’t IMiDs (Revlimid/Pomalyst) or proteasome inhibitors (Veldade/Kyprolis/MLN9708).  Instead, they attack myeloma in different ways.

And if everything goes well, all three could be available to most of us in a few short years.  Now that’s exciting!

Feel good and keep smiling!  Pat

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