Celgene Corporation (NASDAQ:CELG) announced detailed results from the phase III SUNBEAM™ trial evaluating the efficacy and safety of ozanimod, a novel, oral, selective sphingosine 1-phosphate 1 (S1PR1) and 5 (S1PR5) receptor modulator, versus a first-line treatment, Avonex® (interferon beta-1a) (IFN), in patients with relapsing multiple sclerosis (RMS). The results were presented at the MSParis2017 – 7th Joint ECTRIMS – ACTRIMS Meeting, which is being held in Paris, October 25-28, 2017.
“People living with relapsing multiple sclerosis are still in need of additional oral treatment options with favorable benefit-risk profiles,” said Giancarlo Comi, M.D., Professor, Department of Neurology, Università Vita-Salute San Raffaele, Chairman, Department of Neurology and Neurorehabilitation, Scientific Institute, Milan, Italy, and an author of the abstract. “The SUNBEAM data support the potential of ozanimod as a new therapeutic option in this patient population.”
The SUNBEAM study evaluated two doses (1 mg and 0.5 mg) of oral ozanimod in 1,346 patients with RMS in 20 countries treated for at least one year. A significant reduction in annualized relapse rate (ARR) was demonstrated for ozanimod 1 mg (ARR=0.18, p < 0.0001) and for ozanimod 0.5 mg (ARR=0.24, p=0.0013) compared with IFN (ARR=0.35) over an average of 13.6 months of treatment.
Ozanimod demonstrated a significant reduction in new or enlarging T2 lesions over one year for 1 mg (48 percent, p < 0.0001) and 0.5 mg (25 percent, p=0.0032) compared with IFN. A significant reduction in gadolinium-enhanced MRI lesions at 1 year was also demonstrated for ozanimod 1 mg (63 percent, p < 0.0001) and ozanimod 0.5 mg (34 percent, p=0.0182) compared with IFN.
In SUNBEAM, a reduction in brain volume loss, a measure associated with MS disease progression, was observed for the ozanimod dose groups compared with the IFN group. Whole brain volume loss was reduced by 33 percent with the 1 mg dose of ozanimod (median percent change from baseline to 1 year: -0.39, nominally significant p < 0.0001) and by 12 percent in the 0.5 mg group (-0.50, p=0.06) versus IFN (-0.57) at one year.
In a pre-specified pooled analysis of the SUNBEAM and RADIANCE™ Part B studies, ozanimod did not reach statistical significance compared with IFN in the time to 3-month confirmed disability progression. A very low rate of disability progression was observed across all treatment groups. In SUNBEAM, the number of patients with 3-month confirmed disability progression by the end of the study was 13 (2.9 percent) in the ozanimod 1 mg group and 17 (3.8 percent) in the ozanimod 0.5 mg group compared with 19 (4.2 percent) in the IFN group.
Treatment-emergent adverse events (AEs) were experienced by 59.8 percent of patients on ozanimod 1 mg, 57.2 percent on ozanimod 0.5 mg and 75.5 percent on IFN. The most common AEs in ozanimod-treated patients were nasopharyngitis, headache and upper respiratory infection. AEs of alanine aminotransferase increased were low, transient and generally resolved without study drug discontinuation. The overall incidences of serious AEs were similar across treatment arms (ozanimod 1 mg, 2.9 percent; 0.5 mg, 3.5 percent; IFN, 2.5 percent). The percentages of patients who discontinued study drug due to AEs were 2.9 percent for ozanimod 1 mg, 1.5 percent for 0.5 mg and 3.6 percent for IFN.
No second degree or higher atrioventricular blocks were reported. Infection rates were similar across treatment arms; serious infection rates were low and similar across treatment arms, with no serious opportunistic infections in ozanimod-treated patients. The overall safety and tolerability profile was consistent with results from the previously reported phase II RADIANCE Part A study in RMS.
Detailed results from the second phase III trial of ozanimod (RADIANCE Part B) will be presented tomorrow, October 28 at 9:42 a.m. CEST in Hall A.
Shares of Celgene closed yesterday at $99.99, down $19.57 or -16.37% following disappointing earnings. CELG has a 1-year high of $147.17 and a 1-year low of $94.55. The stock’s 50-day moving average is $138.09 and its 200-day moving average is $130.15.
On the ratings front, Celgene has been the subject of a number of recent research reports. In a report released today, JMP analyst Michael King downgraded CELG to Hold. Separately, UBS’s Carter Gould maintained a Buy rating on the stock and has a price target of $120.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Michael King and Carter Gould have a yearly average return of 27.8% and a loss of -1.8% respectively. King has a success rate of 61% and is ranked #173 out of 4702 analysts, while Gould has a success rate of 47% and is ranked #3548.
Overall, one research analyst has rated the stock with a Sell rating, 5 research analysts have assigned a Hold rating and 18 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $150.85 which is 50.9% above where the stock closed yesterday.
Celgene Corp. is an integrated global biopharmaceutical company, which engages in the discovery, development and commercialization of therapies for the treatment of cancer and inflammatory diseases. Its targeting areas include intracellular signaling pathways, protein homeostasis and epigenetics in cancer and immune cells, immunomodulation in cancer and autoimmune diseases and therapeutic application of cell therapies. The company’s products include Revlimid, Vidaza, Thalomid, Pomalyst/Imnovid, Abraxane, and Istodax.