After a highly successful American Society of Hematology meeting in San Francisco earlier this week, Celgene has been further boosted by positive data for Abraxane at the San Antonio Breast Cancer Symposium.
Results from a Phase III trial sponsored by the German Breast Group (GBG) demonstrated significant benefit for patients on Abraxane (nab-paclitaxel) with early high risk breast cancer when compared to conventional solvent-based paclitaxel. The 1,200-patient study found a statistically significant and clinically meaningful 9% absolute improvement (from 29% to 38%) in the pCR (pathological complete response) rate, when neoadjuvant (i.e. preoperative) chemotherapy was started with Abraxane instead of paclitaxel followed by epirubicin/cyclophosphamide, given all before surgery.
The final dose of Abraxane used was 125mg/m2, about half of the recommended dose used for refractory breast cancer (260mg/m2). The latter dose was reduced as toxicities had led to more discontinuations for the Celgene drug (17% vs 6%), although they were fewer incidents of local disease (1.7% vs 5%).
Gunter von Minckwitz, chairman of GBG, a network of over 500 study centres in Germany, said this is the first time in 18 years of the group running neoadjuvant studies that pCR rates “could be strongly increased by replacing a key component of the standard neoadjuvant chemotherapy instead of just adding additional agents to it”.
Could add $1 billion to sales
He added that “long-term outcome data have to be awaited to confirm that this short-term benefit to patients is maintained”, but the results have caused excitement. The US Food and Drug Administration has accepted pCR as a surrogate marker for accelerated approval in high-risk breast cancer and Nomura analyst Ian Somaiya believes the neoadjuvant setting could add an extra $500million-$1 billion to Abraxane sales.
Abraxane is approved for advanced breast cancer in people who have already received certain other medicines or when the cancer has come back within six months of treatment after surgery. It is also available for advanced non-small cell lung and pancreatic cancers.
In a research note, Mr Somaiya said Celgene “remains our top large-cap pick heading into 2015”, noting that approval is expected for its big-earning Revlimid (lenalidomide) as front-line/maintenance multiple myeloma therapy in Europe and the USA soon.
This and emerging data in lymphoma “open up a $3-$4 billion opportunity” for the drug, he added, claiming that ASH data “pointed to triple combos that firmly establish Revlimid as a backbone in myeloma”.
Celgene was referred to by many attendees as the star of the show at ASH, thanks to its own drugs and the impressive pipeline it has garnered through partnerships with the likes of Agios and Acceleron (see links).