Celgene has been boosted by late-stage data showing that its breast cancer drug Abraxane helps melanoma patients live longer without their disease progressing.
The company announced top-line results of a Phase III study of Abraxane (nanoparticle albumin bound -'nab' - paclitaxel) in 529 chemotherapy-naive patients with metastatic melanoma which demonstrated statistically significant improvement in progression-free survival (PFS) compared to patients receiving dacarbazine chemotherapy. The latter drug, also known as DTIC, is the only chemotherapy approved since 1975 by the FDA for metastatic melanoma.
Celgene did not offer much more detail about the trial, saying that the data will be presented at the Society for Melanoma Research Congress in Los Angeles in November. The firm added: "Future regulatory and clinical strategies are being reviewed in light of these results."
Abraxane is approved for breast cancer and is being reviewed by the FDA for non-small cell lung cancer. A decision is scheduled in the next fortnight and Celgene is also expected to unveil data from an eagerly-anticipated Phase III trial in pancreatic cancer before the end of the year.
Excitement at ESMO over GSK melanoma combo
If all goes well, Abraxane could compete with Roche's BRAF inhibitor Zelboraf (vemurafenib) and Bristol-Myers Squibb's cancer vaccine Yervoy (ipilimumab). Melanoma dominated much of the interest around the just-finished European Society of Medical Oncology conference in Vienna, most notably Phase II data on a combination of GSK's investigational BRAF inhibitor dabrafenib and the firm's MEK inhibitor trametinib.
Georgina Long from the Melanoma Institute Australia reported that combining the two drugs provided a clinically meaningful improvement in progression-free survival (PFS), response rate and duration of response in 162 patients with melanoma that had BRAF V600 mutations.
Patients in the study received either dabrafenib 150mg twice daily, twice-daily dabrafenib plus once-daily 1mg trametinib or twice daily dabrafenib plus once-daily 2mg trametinib. The combination prolonged PFS over single-drug therapy from 5.8 months to 9.4 months, which represents a 60% improvement. Among patients who received both drugs at the higher dose, 41% had not progressed 12 months after treatment began, compared to 9% in the monotherapy arm.
Dr Long told reporters at ESMO that the safety profile of the combo was also striking, saying: "Never, ever in the history of drug development have we combined two drugs and seen a reduction in toxicity."