Pharma Strategy Blog

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!