This week I’ll be attending the World Congress on Osteoporosis, Osteoarthritis and Muscluloskeletal Diseases (WCO-IOF-ESCEO), which is being held in Krakow, Poland from 19th-22nd April. Since last year’s congress in Florence, several key events have shaped the osteoporosis treatment landscape. In May 2017, Amgen/UCB announced a cardiovascular signal was observed in the Phase III ARCH trial for Evenity (romosozumab). The consequence was that the FDA rejected their submission, and requested additional trial data in any resubmission. If this is approved, Evenity now isn’t expected to launch until at least 2019. There was better news for Radius Health’s Tymlos (abaloparatide), which was approved by the FDA in April 2017, and has recorded strong sales since its launch the following month in the United States. However, Radius Health hasn’t had it all its own way; in March 2018, the CHMP decided not to recommend market approval for Tymlos in Europe. Radius Health has said it will appeal the decision, but this will further delay Tymlos’s European launch. This delay brings it ever closer to the launch date of expected Forteo biosimilars, and the additional competition that they will provide.
What results can we expect from WCO-IOF-ESCEO this year that may affect the osteoporosis market? No new major study results are expected, with most presentations further analysing previously published trials data. However, these are the talks I think will have the highest impact.
- Tymlos – Three talks will be on Tymlos, focusing on its cost-effectiveness and efficacy. However, the most interesting looks to be an updated meta-analysis presented by Dr. Jean-Yves Reginster. Any analyses that strengthens Tymlos’s already impressive efficacy data, could help to further differentiate it against Eli Lilly’s Forteo (teriparatide).
Abaloparatide for risk reduction of nonvertebral and vertebral fractures in postmenopausal women with osteoporosis: an updated network meta-analysis. Presenting author: J. Y. Reginster.
- Evenity – Two talks will concentrate on Evenity, with the most exciting focusing on the Phase III FRAME trial. This talk will likely emphasize the importance of sequential therapy – treating patients with an anabolic agent followed by an antiresorptive – a treatment method that many thought leaders I have interviewed are keen to see occur more frequently.
FRAME study: the foundation effect of rebuilding bone with one year of romosozumab leads to continued lower fracture risk after transition to denosumab. Presenting author: S. Ferrari.
- Forteo – Data on Forteo will be presented at one of the satellite symposiums being held in the same venue, sponsored by Eli Lilly. The pick of these talks looks likely to focus on new data from the VERO clinical trial. This trial was the first to compare osteoporosis drugs (Forteo vs. risedronate) with incident fractures as the primary outcome. Eli Lilly will be looking to reinforce Forteo’s efficacy credentials, which are facing tough competition from emerging therapies.
New Results of the Active Comparator VERO Clinical Trial. Presenting author: Salvatore Minisola.
- Prolia – Several presenters will be discussing data from long-term studies on Prolia use. Perhaps the most interesting of these will be examining the occurrence of osteonecrosis of the jaw (ONJ) in Prolia patients. Patient fear of this serious, but rare, side-effect has dramatically increased patients’ reluctance to be prescribed bisphosphonates. Amgen will be keen for any data that shows a lower risk of ONJ in Prolia treated patients, so the same negative publicity doesn’t occur for its therapy.
Evaluation of invasive oral procedures and events in women with postmenopausal osteoporosis treated for up to 10 years with denosumab: Results from the Phase 3 FREEDOM open-label extension. Presenting author: P.W. Butler.
On top of these talks, there will be a whole raft of presentations focusing on a wide variety of topics. Several speakers will be discussing ways to improve the large treatment gap observed in osteoporosis patients, with many of these concentrating on the use of fracture liaison services and FRAX.
Are there any talks you’re particularly looking forward to seeing at the WCO-IOF-ESCEO this year? Disagree with my choices of the top-picks? Let me know. I’ll be attending the conference, so would love to chat with you, or you can get in touch via email/twitter.