Pfizer Inc said on Friday its cancer drug Ibrance did not meet the main goal in a late-stage trial in early breast cancer patients with residual invasive disease following neoadjuvant chemotherapy, the latest setback in the company's attempt to expand the use of the drug to treat early stages of the disease. Ibrance failed to meet the main goal of improved invasive disease free survival. The PENELOPE-B study compared one year of Ibrance plus at least five years of standard adjuvant endocrine therapy to placebo plus at least five years of standard adjuvant endocrine therapy in 1,250 women with HR+, HER2- eBC at high risk of recurrence who have residual invasive disease after completing neoadjuvant chemotherapy. The latest development comes after an independent data monitoring committee said in May a similar trial comparing Ibrance plus an endocrine therapy to a standalone endocrine therapy to treat early-stage breast cancer was unlikely to meet the main goal. Ibrance is already approved in the United States to treat certain adult patients with advanced breast cancer which has spread to other parts of the body. The drug has not yet been approved for treating early stages of the disease. This puts the drug at a relative disadvantage to rival Eli Lilly and Co, which in June posted data showing that its drug Verzenio, met the trial goal of reducing the risk of early-stage breast cancer from recurring. "Today's data leaves Lilly's Verzenio as the clear winner in the adjuvant space for now, giving Verzenio a blockbuster opportunity in a potential early breast cancer indication," Cantor Fitzgerald analyst Louise Chen said. —Reuters Staff Source
