Lampalizumab Does Not Meet Primary Endpoint

Genentech reported yesterday that lampalizumab did not meet the primary endpoint in SPECTRI, one of the two parallel Phase III clinical trials investigating lampalizumab injections for the treatment of geographic atrophy (GA) in AMD.

Lampalizumab was the first treatment to enter Phase III studies for GA, a prevalent and debilitating disease with unmet need for a treatment. Lampalizumab is the Fab portion of a monoclonal antibody against complement factor D, which showed promising results in the Phase II MAHALO study (although the data was driven by a genetic subset of participants identified post hoc).

There was a lot of buzz around the potential treatment: some of us had high hopes, while some of us were skeptical. In either case, it was certainly a ray of hope for many patients suffering from advanced non-neovascular AMD.

Geographic Atrophy

SPECTRI and CHROMA are identically designed parallel global studies, that examine the efficacy and safety of lampalizumab injected every 4 or 6 weeks, compared to sham injections. The primary endpoint was to determine whether lampalizumab slowed the progression of GA at 1 year, as measured by autofluorescence.

The endpoint was not met in SPECTRI. The read out for CHROMA is anticipated to be in November. While we hope that there will be better news, yesterday’s press release certainly stifled the momentum for non-neovascular AMD treatment.

Yoshihiro Yonekawa, M.D.