The American Society of Haemotology meeting is one of the punctuation marks of the lifescience year, and usually features some of the most important developments in biotech with data on new therapies for blood cancers.
This year is no different, with Pharmacyclics hoping to bounce back from disappointing trial results for ibrutinib in multiple myeloma and Seattle Genetics shooting to regain momentum for Adcetris. For European companies, it is all about extending franchises, with Novartis, Sanofi and Roche looking to new agents to replace products reaching the end of their market exclusivity or move into new types of haematological malignancies.
Pharmacyclics took a big hit when it announced disappointing data from a phase II trial of its Johnson & Johnson-partnered kinase inhibitor ibrutinib, with shares dropping 11% on the news (Pharmacyclics hammered after ibrutinib low-dose miss, November 6, 2012). The trial was in the lowest dose tested, and this and the promise of two other doses, including one in combination with dexamethasone, has helped shares recover slightly in the two weeks since, as investors look again at the trial; positive news in other indications at ASH is probably helping.
The California group will report more positive data for the Bruton’s tyrosine kinase (Btk) inhibitor, signed for an impressive $150m last year (J&J pays handsomely for first-in-class blood cancer drug, December 9, 2011). Among the data are 22-month results from a phase Ib/II trial in first and second-line chronic and small lymphocytic leukaemia. There will also be data in relapsed and refractory mantle cell lymphoma, diffuse large B-cell lymphoma, and follicular lymphoma, where signs of efficacy should raise confidence that the compound can advance toward registration.
Seattle Genetics’ antibody-drug conjugate Adcetris has had an up-and-down time of it since winning approval in second or third-line Hodgkin's lymphoma. Forecasts have fallen by more than a fifth from their peak, which coincided with the September 2011 launch (Adcetris wins broad approval and high price but caution justified, August 22, 2011). A black box warning of progressive multifocal leukoencephalopathy has probably not helped, but the product has faced some difficult market dynamics – third-quarter sales fell below expectations, and management cut the company’s guidance and forecast a flat sales trajectory through 2013.
Thus signs from ASH of potential use in additional indications will be taken as a positive. Efficacy in frontline treatment of anaplastic large cell lymphoma and Hodgkins lymphoma as well as relapsed CD30-positive non-Hodgkin lymphomas should build some confidence the agent has potential to expand.
A more optimistic view could be taken of Celgene, which in addition to Revlimid in a number of haematological cancers has high hopes for pomalidomide at ASH (Event – Celgene looks to poma to pick up some Revlimid slack, November 20, 2012).
Meanwhile, 12-month data are expected from Ariad Pharmaceuticals’ Pace trial of ponatinib in leukaemia patients who progress on Sprycel or Tasigna or have the T315I BCR-ABL mutation; Array BioPharma’s kinesin spindle protein inhibitor ARRY-520 showed early signs of promise in myeloma patients who progressed after treatment with Velcade and immunomodulatory drugs, particularly in combination with low-dose dexamethasone; and Gilead Sciences will have data for GS-1101 that will support advancing the project into phase III in chronic lymphocytic and non-Hodgkin's lymphomas.
Big pharma circles the wagons
Novartis, staring down the loss of market exclusivity for its biggest seller Gleevec in 2015, is eager to show off the value of replacement Tasigna – data from a switching trial will be detailed – as well as the value of its newest haematological drug Jakavi. Nipping at Jakavi’s heels in myelofibrosis will be Sanofi’s SAR302503 – the French company itself is suffering the loss of revenue from chemotherapy drugs Taxotere and Eloxatin, which are losing patent protection.
Roche, meanwhile, is releasing data from a trial of subcutaneous Rituxan in follicular lymphoma. That formulation should help the Swiss company shorten administration time and help protect its biggest seller from biosimilar entry, which could occur in 2014.
Other agents expected to make a splash are Genmab’s J&J-partnered antibody daratumumab, Merck & Co’s kinase inhibitor dinaciclib and Takeda’s proteasome inhibitor MLN9708.
|Selected trials detailed at ASH|
|Pharmacyclics||ibrutinib||NCT01589302 (chronic and small lyphocytic leukaemias)|
|NCT01599949 (mantle cell lymphoma)|
|Ariad Pharmaceuticals||ponatinib||NCT01207440 (Pace trial)|
|Seattle Genetics||Adcetris||NCT01309789 (anaplastic large cell lymphoma)|
|NCT01421667 (non-Hodgkin's lymphoma)|
To contact the writer of this story email Jonathan Gardner in London at email@example.com