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Categorized | News, Research

Best of ASH (Part Three)

Posted on January 10 2014 by Pat Killingsworth | 852 views

I have been remiss not passing along data from one of the hottest new therapies for multiple myeloma,  ARRY-520.

I saved this press release from the drug’s parent company, Array BioPharma, Inc, to post after the dust settled, post ASH.  Let’s discuss on the other side:

 

Array BioPharma Provides Clinical Update On Filanesib (ARRY-520) For Multiple Myeloma At The 2013 American Society of Hematology Meeting


Filanesib demonstrated clinical activity as a single agent and in combination with proteasome inhibitors
Biomarker for filanesib may enable patient selection
BOULDER, Colo., Dec. 9, 2013 /PRNewswire/ — Array BioPharma Inc. (NASDAQ: ARRY) announced positive data for newly named filanesib (ARRY-520) as a single agent and in combination with proteasome inhibitors (PI) in patients with multiple myeloma (MM) at the 2013 Annual Meeting of the American Society of Hematology. Filanesib is a highly selective, targeted KSP inhibitor with a mechanism of action distinct from currently available drugs to treat MM such as immunomodulatory drugs (IMiD) and PIs.  Across multiple studies, filanesib has demonstrated activity in heavily pre-treated MM patients, with a consistent safety profile including no drug-induced peripheral neuropathy and limited non‘hematologic toxicity.  Adverse events are generally limited to transient, non-cumulative and predominantly asymptomatic hematologic effects. 

“Filanesib has shown clinical activity in relapsed/refractory multiple myeloma patients, both as a single agent, and in separate combination trials with Kyprolis and Velcade,” said Jatin J. Shah, M.D., Assistant Professor, Lymphoma/Myeloma, Division of Cancer Medicine, The University of Texas, MD Anderson Cancer Center.  “These results support advancing filanesib into pivotal trials to confirm the promising activity we’ve seen to date.”

“Multiple myeloma remains an incurable disease, with a significant unmet medical need in patients who are relapsed/refractory to IMiDs and proteasome inhibitors,” said Michael Needle, M.D., Chief Medical Officer, Array BioPharma.  “Filanesib is a first-in class drug in myeloma that is well tolerated and has shown very encouraging clinical activity in heavily pretreated patients who have limited therapeutic options.  Furthermore, we are excited about the potential of our patient selection marker, AAG, which should help us identify which patients have the best chance to benefit from receiving filanesib.”

Below are highlights of each presentation.  The posters and presentation slides are available as PDFs on Array’s website at www.arraybiopharma.com.

Phase 1b Dose Escalation Trial – Filanesib in Combination with Kyprolis® (carfilzomib) Interim data from an ongoing investigator initiated combination trial of filanesib with Kyprolis in patients with relapsed or refractory MM were reported at the conference.  100% of these patients were refractory or intolerant to Velcade® (bortezomib), while 80% were refractory or intolerant to Revlimid® (lenalidomide) and 30% had received prior treatment with filanesib or Kyprolis. The combination demonstrated early signs of activity, with a 37% overall response rate (ORR) (≥ partial response) and 63% clinical benefit rate (CBR) (≥ minor response). In addition, the trial demonstrated that filanesib and Kyprolis can be combined at the maximum planned dose for each agent.  The combination has been well tolerated with hematologic toxicity effectively managed with supportive measures.

Phase 1b Dose Escalation Trial – Filanesib in Combination with Velcade Interim data from an ongoing combination trial of filanesib with Velcade in patients with relapsed or refractory MM were reported at the conference. These patients had relapsed or refractory disease to Velcade with a median of five prior treatments. The combination demonstrated early signs of activity with a 42% ORR in patients dosed at greater than or equal to 1.25 mg/m2 filanesib in Schedule 1 (filanesib administered on Days 1, 2, 15 and 16 every 4 weeks). For the subset of Velcade-sensitive patients, the ORR was 63%, while for PI-refractory patients it was 30%.  In addition, the trial demonstrated that filanesib and Velcade can be combined at the maximum planned dose for each agent.  The combination has been well tolerated with limited hematologic toxicity effectively managed with supportive measures.  There was a low incidence of non-hematologic adverse events which were predominantly Grade 1 / 2 and there was a very low incidence of peripheral neuropathy.

Phase 2 Trial – Filanesib Single Agent and in Combination with Dexamethasone Mature data from a Phase 2 trial in heavily pretreated MM patients were reported at the conference.  In patients with a median of six prior therapies, previously treated with both Velcade and Revlimid, single-agent filanesib demonstrated a 16% ORR. In patients with a median of eight prior therapies, who were dual refractory to Velcade and Revlimid, filanesib in combination with dexamethasone demonstrated a 15% ORR.  There was a low incidence of non-hematologic adverse events, including no peripheral neuropathy.  Hematologic toxicities were characterized as transient, non-cumulative and asymptomatic and were effectively managed with supportive measures.

In addition, the retrospective use of AAG (acute phase protein alpha-1-acidic glycoprotein) levels as a patient selection marker improved the ORR results to 24% of patients receiving single-agent filanesib and 19% of dual-refractory patients receiving filanesib and dexamethasone. In the single-agent portion of the trial, median overall survival in AAG-low patients was 23.3 months.

Also of note, filanesib demonstrated clinical activity in patients previously treated with newer myeloma agents, including Kyprolis, MLN9708 and/or Pomalyst® (pomalidomide), suggesting filanesib maintains activity in patients resistant to multiple PI and IMiD drugs.  In this population, filanesib had an ORR of 21% which improved to 33% in an AAG-selected population.

About Filanesib for MM Filanesib is a highly selective, targeted KSP inhibitor with a mechanism of action distinct from currently available drugs to treat MM.  Filanesib has demonstrated clinical activity as a single-agent as well as in separate combination trials with Kyprolis and Velcade in heavily pretreated patients.  Across these studies, filanesib has demonstrated a consistent safety profile including no drug-induced peripheral neuropathy and limited non-hematologic toxicity.  Adverse events have been generally limited to transient, non-cumulative and predominantly asymptomatic hematologic toxicities, effectively managed with supportive measures.    

Based on the strength of data from ongoing or completed clinical trials, and recent positive discussions with the Food and Drug Administration, Array expects to initiate a global Phase 3 study of filanesib in patients with RRMM, of which there are more than 70,000 patients in developed countries.   The trial will evaluate filanesib in several hundred patients with RRMM, comparing Kyprolis plus filanesib to Kyprolis alone, with Progression Free Survival as the primary endpoint.  Secondary endpoints include Overall Survival and safety and efficacy differences between patients with low and high levels of Baseline AAG, a potential patient selection marker for response to filanesib.  The trial design may include an analysis of Objective Response Rate, which, if positive, could support an accelerated regulatory filing in the United States.  

About Multiple Myeloma Multiple myeloma is a cancer of the plasma cells in the bone marrow and is the second most common hematologic malignancy in the United States.  Despite advancements with new treatments, including IMiDs and proteasome inhibitors, MM remains a fatal disease for most patients.  Therefore, new drugs with novel mechanisms of action are needed to address the unmet need in the treatment of patients with MM.

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.  Seven Phase 3 or pivotal studies are already in progress, or are planned to begin, within the next year. These programs include the wholly-owned hematology drug, filanesib (ARRY-520), for multiple myeloma and two partnered cancer drugs, selumetinib (AstraZeneca) and MEK162 (Novartis).  For more information on Array, please go to www.arraybiopharma.com

 

ASH-logo-purpleCan’t get used to calling it, “filanesib.”  Let’s stick with ARRY-520.

This was THE hot new drug at ASH 2012 in Atlanta.  But interest tailed off a bit this year.  Note the underwhelming 16% response rate as a single agent.

But it is way too early to become discouraged!  Researchers are desperate to discover new pathways so they can attack myeloma in different ways.  Why not a KSP inhibitor?

Yet promising results when using ARRY-520 in combination with other myeloma therapies leaves me feeling hopeful.  Sample sizes may be small, but that’s where realistic hope lies.

Feel good and keep smiling!  Pat

2 Comments For This Post

  1. Ron Harvot Says:

    i still find this news very encouraging. Keep in mind most of these patients were already refractory to Velcade and/or Krypsolis. As a single agent it was not that impressive with this population but in combination it appears to work well with drugs that were no longer working for this group. I find that fascinating and encouraging. I wonder if an ImiD was added to the mix what would result?

    Ron

  2. Pat Killingsworth Says:

    I believe they’re working on that, Ron.

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