Seattle Genetics, Inc. (NASDAQ:SGEN) announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing a supplemental Biologics License Application (BLA) for ADCETRIS (brentuximab vedotin) in the AETHERA setting for the post-transplant consolidation treatment of Hodgkin lymphoma (HL) patients at high risk of relapse or progression. The FDA granted Priority Review for the application and the Prescription Drug User Fee Act (PDUFA) target action date is August 18, 2015. The submission of the supplemental BLA is based on positive results from a phase 3 clinical trial called AETHERA that was designed to determine if 16 cycles of ADCETRIS as consolidation therapy immediately following an autologous stem cell transplant (ASCT) could extend progression-free survival (PFS) in HL patients at high risk of relapse or progression. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, which is expressed in classical HL and systemic anaplastic large cell lymphoma (sALCL), as well as other lymphoma subtypes. ADCETRIS is approved in relapsed HL and sALCL but is currently not approved for consolidation therapy in HL patients immediately after ASCT.
Globally, there are more than 65,000 cases of HL diagnosed each year. Although frontline combination chemotherapy can result in durable responses, up to 30 percent of these patients relapse or are refractory to frontline treatment. The standard for these patients is to proceed to an ASCT but approximately half of all HL patients who undergo an ASCT experience subsequent disease relapse.
“The FDA’s filing of our supplemental BLA and priority review designation for ADCETRIS as consolidation therapy represents a significant milestone towards our goal of making ADCETRIS available to high risk HL patients immediately following an autologous stem cell transplant who currently have no therapeutic options to prevent progression,” saidClay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “The phase 3 AETHERA trial demonstrated that using ADCETRIS in this setting significantly improved progression-free survival with a manageable safety profile. We look forward to working with the FDA during their review of our application for approval of this additional indication for ADCETRIS.”
The positive results from the phase 3 AETHERA trial were published in The Lancet in March 2015 and were presented at the 56th American Society of Hematology (ASH) Annual Meeting in December 2014. Results from the AETHERA trial in 329 HL patients at high risk of relapse following ASCT included:
- The trial achieved its primary endpoint and demonstrated a significant increase in PFS per independent review facility, with a hazard ratio of 0.57 and a p-value of 0.001. Median PFS was 43 months for patients who received ADCETRIS versus 24 months for patients who received placebo. The two-year PFS rate was 63 percent in the ADCETRIS arm compared to 51 percent in the placebo arm.
- The PFS benefit was consistent across all pre-specified subgroups, including primary refractory patients, patients who relapsed within twelve months of frontline therapy and patients who relapsed after twelve months with extranodal disease.
- ADCETRIS-treated patients received a median of 15 treatment cycles and 48 percent received the maximum of 16 cycles, indicating generally acceptable tolerability and a manageable adverse reaction profile.
- The most common adverse events in the ADCETRIS arm were peripheral sensory neuropathy (56 percent), neutropenia (35 percent), upper respiratory tract infection (26 percent), fatigue (24 percent) and peripheral motor neuropathy (23 percent). The most common adverse events in the placebo arm were upper respiratory tract infection (23 percent), fatigue (18 percent) peripheral sensory neuropathy (16 percent), cough (16 percent) and neutropenia (12 percent). Eighty-five percent of patients with peripheral neuropathy on the ADCETRIS arm had resolution or improvement in symptoms with a median time to improvement of 23.4 weeks.
Submission of safety data from the AETHERA trial to the FDA is a post-marketing requirement. (Original Source)
Shares of Seattle Genetics opened today at $36.81 and are currently trading up at $37. SGEN has a 1-year high of $44.95 and a 1-year low of $30.05. The stock’s 50-day moving average is $36.68 and its 200-day moving average is $34.64.
On the ratings front, Seattle Genetics has been the subject of a number of recent research reports. In a report issued on February 11, Cantor Fitzgerald analyst Mara Goldstein maintained a Hold rating on SGEN, with a price target of $35, which represents a slight downside potential from current levels. Separately, on the same day, Merrill Lynch’s Steve Byrne reiterated a Sell rating on the stock .
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Mara Goldstein and Steve Byrne have a total average return of 23.0% and 14.2% respectively. Goldstein has a success rate of 71.7% and is ranked #165 out of 3573 analysts, while Byrne has a success rate of 55.6% and is ranked #555.
The street is mostly Bullish on SGEN stock. Out of 10 analysts who cover the stock, 5 suggest a Buy rating , 4 suggest a Hold and one recommend to Sell the stock. The 12-month average price target assigned to the stock is $47.86, which represents a potential upside of 30.0% from where the stock is currently trading.
Seattle Genetics Inc is a biotechnology company. It develops and commercializes monoclonal antibody-based therapies for the treatment of cancer and autoimmune disease.