Pharma Strategy Blog

Commentary on Pharma & Biotech Oncology / Hematology New Product Development

On Friday, many of us interested in hematology and oncology will be heading to New Orleans and the annual American Society of Hematology (ASH) meeting.  Every year, I like to try and predict what might be hot topics beforehand, although I'm not always right!

So without breaking any embargoes, based on companies, drugs, and data that I've been following this year, here's my list of Pharma companies to watch out for:

  1. Celgene: Revlimid is doing well in the refractory setting and will likely have some stunning data in the front-line setting in multiple myeloma.  Data was released in July this year suggesting that patients live longer on the drug, paving the way for maintenance therapy as a viable option.  This is not good news for Millennium and J&J in the long run, who promote Velcade.  However, in the short term, Millennium still have a huge advantage over their rivals given they they have demonstrated long term survival data in the newly diagnosed setting, which Revlimid does not have.  It's clearly time to step up the R&D and marketing efforts a few notches now that the competition is getting hot.  Millennium do have a promising neddylation inhibitor, MLN4924, up their sleeve and I'm looking forward to seeing the latest data on that too.
  2. Novartis: Tasigna front-line data is being presented as a late breaking abstract suggesting that is achieves deeper and earlier complete cytogenetic responses than Gleevec, the standard of care.  It looks like the company will have likely beaten BMS and Sprycel in the race to file the 2nd generation TKI's in newly diagnosed CML.  Afinitor is being developed beyond renal cell carcinoma in many indications, including NHL.
  3. GSK: Arzerra has now been approved for the treatment of chronic lymphocytic leukemia (CLL) in patients who have become refractory to fludarabine and alemtuzumab.  Updated data in NHL is expected at this meeting.

Biotech companies also look to be well represented, although most of the data will be phase I and II, rather than big phase III studies:

  1. Onyx/Proteolix: Carfilzomib is a 2nd generation proteasome inhibitor that appears to spare patients some of the peripheral neuropathy associated with Velcade.  The agent has been doing well in trials to date and new, mature data is expected at ASH.
  2. Ariad: AP24534 is a TKI which appears to inhibit the T315i mutation not targeted by imatinib, dasatinib or nilotinib.  Although this mutation is rare, it is fatal as there are no approved options to target it at present.
  3. AEtena Zentaris/Keryx: Developing perifosine in myeloma.  Combination data with Velcade and dexamethasone is expected to be presented at ASH, see the link to the press release on the poster below.
  4. Seattle Genetics: Have had a rocky ride lately with the halting of dacetuzumab in combination with rituximab in diffuse large cell B-lymphomas but are presenting an update at the meeting.  They have another compound, brentuximab, in development for CD-30+ lymphomas.
  5. Trubion: TRU-016 is an anti-CD37 small modular immunopharmaceutical (SMIP™) protein in development for CLL, which they licensed from Facet. It's far to early to tell whether this agent has any promise, but worth watching, just in case.

Of course, there are also some others, such as Allos Therapeutics pralatrexate and Gloucester Pharma's romidepsin, but these have been recently approved in rare forms of NHL, ie PTCL and CTCL respectively. It will be interesting to see how and where they plan to expand to other indications outside the orphan drug designated initial approvals.

Calistoga and Semafore are both developing PI3 Kinase inhibitors in hematologic indications such as refractory B-cell malignancies and myeloma, respectively.  The data is still very immature, being phase I trials, but worth looking at since many of the big pharma company PI3 kinases are being tested in solid tumours rather than hematological cancers.

I'll be posting daily reports from the ASH meeting, so watch this space!

4 Responses to “ASH – what's hot news this year?”

  1. Karl Simpson

    Interesting summary.
    The information from Celgene is much anticipated and in particular the analysts look forward to hearing the data as it could have a signifcant impact on the commerical possibilities for Revlimid.
    We look forward to the news coming out of this hematology / oncology meeting.

  2. MaverickNY

    Karl, yes if the data lives up to expectations, Revlimid looks well positioned for increased use in the front line setting in myeloma and increased revenues.

  3. Jill Carson

    Hi Sally. I’m intrigued by Ariad’s ‘534 for CML. They apparently have some stunning phase I results (that will be revealed at ASH on Monday), and supported by an unusual conference call the next day at 8:30 AM with the Chairman of the MD Anderson hematology department. The Chairman of Ariad has repeatedly stated that they expect to move forward with a Phase III registration trial (skipping phase II) in 2010 with ‘534. That, along with the second interim results for their phase III trial for Ridaforolimus (for metastatic Sarcoma, first new treatment for Sarcoma in 25 years) in Q1 2010, means that Ariad could have 2 drugs in phase III trials in 2010. How can the stock only be at $2.45 (as of today)?

  4. MaverickNY

    Hi Jill, sorry I meant to comment before, but things got very hectic in the run up to ASH.
    Who knows why the market is sceptical and unsure enough to keep the price down?
    The AP24534 data looked interesting, especially in advanced patients who had previously relapsed on 2nd generation TKIs, but we should remember that this is a very small market given 65-70% of imatinib patients achieve a CCyR and 50% of patients do very well on 2nd line TKIs.
    As for ridoforolimus, well, it’s an interesting mTOR compound but there are two factors that make investors nervous:
    1) It is a placebo controlled trial and FDA have recently had a run of ODAC meetings where they declined to approve oncology drugs in the refractory setting vs. placebo.
    2) The sarcoma trial was an allcomers trial so that means subtypes that may not have responses will be lumped in with those that are highly responsive, potentially cancelling out any significant benefit.
    My guess is that the market is efficiently waiting to see compelling data before investing more seriously.

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