
Regeneron could reap big rewards from high-dose Eylea
Regeneron’s 19% stock surge yesterday added $12bn to its market cap, taking its valuation higher than that of the pharma giant GSK; investors were clearly impressed with data on high-dose Eylea. Two crucial pivotal trials succeeded in showing that the project, given at four-monthly intervals, worked as well as the original formulation, dosed every two months. Long-acting Eylea is a vital component of Regeneron’s defence against biosimilars, which could start in the US in 2024. And because the high-dose product will probably be filed under a new BLA it might be exempt from Medicare price negotiations. Analysts reckon the high-dose product could also help fend off a new rival, Roche’s bispecific Vabysmo, which is also available at long dosing intervals. SVB Securities pointed out that 77% of wet AMD patients managed to stay on high-dose Eylea dosed every four months, versus 45% for Vabysmo on this schedule. Echoing upgrades from across the sellside the bank substantially hiked future Eylea forecasts, adding a huge 30% to their 2030 estimate, to $17bn. Still, Roche recently presented two-year data showing that 45% had improved to 60% at two years, so the Vabysmo threat is far from neutralised.
Eylea vs Vabysmo in wet AMD | |||||||
---|---|---|---|---|---|---|---|
Pulsar (NCT04423718) | Tenaya (NCT03823287) | Lucerne (NCT03823300) | |||||
Drug | Eylea (control) | Eylea 8mg |
Eylea 8mg |
Eylea 2mg (control) |
Vabysmo | Eylea 2mg (control) |
Vabysmo |
Regimen | Q8wk | Q12wk | Q16wk | Q8wk | Variable | Q8wk | Variable |
N | 336 | 335 | 338 | 337 | 334 | 337 | 331 |
Mean observed BCVA improvement (letters) | 7.6 | 6.7 | 6.2 | 6.6 | 5.8 | 5.1 | 6.6 |
LS mean difference in BCVA improvement (primary endpoint) | -0.97 | -1.14 | 0.7 | 0.0 | |||
Non-inferiority p-value* | 0.0009 | 0.0011 | |||||
Patients maintained on dosing interval, without need for regimen modification | 79% | 77% | 45%** | 45%** | |||
*Non-inferiority (1-sided) p-values are for the difference in least squares mean compared to Eylea with margin of 4 letters. **16wk regimen. BCVA=best corrected visual acuity; LS=least square. |
Eylea vs Vabysmo in diabetic macular oedema | |||||||||
---|---|---|---|---|---|---|---|---|---|
Photon (NCT04429503) | Yosemite (NCT03622580) | Rhine (NCT03622593) | |||||||
Drug | Eylea (control) | Eylea 8mg |
Eylea 8mg |
Eylea (control) | Vaby-smo | Vabysmo | Eylea (control) | Vaby-smo | Vabysmo |
Regimen | Q8wk | Q12wk | Q16wk | Q8wk | Q8wk | Variable | Q8wk | Q8wk | Variable |
N | 167 | 328 | 163 | 312 | 315 | 313 | 315 | 317 | 319 |
Mean observed BCVA improvement (letters) | 9.2 | 8.8 | 7.9 | 10.9 | 10.7 | 11.6 | 10.3 | 11.8 | 10.8 |
LS mean difference in BCVA improvement (primary endpoint) | -0.6 | -1.4 | -0.2 | 0.7 | 1.5 | 0.5 | |||
Non-inferiority p-value* | <0.0001 | 0.0031 | |||||||
Patients maintained on dosing interval, without need for regimen modification | 91% | 89% | |||||||
*Non-inferiority (1-sided) p-values are for the difference in least squares mean compared to Eylea with margin of 4 letters. Yosemite and Rhine data are averages of weeks 48, 52 and 56. BCVA=best corrected visual acuity; LS=least square. |