* Trial positive despite negative interim data
* To submit marketing application for mono, combo therapy in
* The odds of monotherapy approval have improved - Bernstein
(Adds details, analyst comments; updates shares)
By Natalie Grover
March 20 Eli Lilly and Co's combination
of its experimental breast cancer drug and another widely used
treatment slowed disease progression in patients who relapsed or
did not benefit enough when treated with the anti-estrogen
In August, an independent data monitoring committee
recommended the late-stage study continue without modification,
even though interim evaluation suggested the combination
treatment was not delaying cancer progression.
Lilly's drug, abemaciclib, is part of the same new class of
breast cancer treatments as Pfizer Inc's Ibrance, and
Novartis AG's newly approved Kisqali.
The study, named Monarch-2, compared combined use of
abemaciclib and anti-estrogen therapy fulvestrant with
Lilly said on Monday that data showed the addition of
abemaciclib, which is also being evaluated for lung cancer,
resulted in a statistically significant improvement in
The U.S. drugmaker is also evaluating the drug as a single
agent in breast cancer patients who have not derived enough
benefit from prior treatments, and multiple other studies are
testing abemaciclib in combination with other drugs.
Lilly said it planned to submit an application to market
abemaciclib as a monotherapy in the second quarter, and as a
combination therapy in the third quarter.
If approved, abemaciclib will be the third entrant to the
U.S. market, more than two years after Ibrance, and just over
six months behind Kisqali.
With Monarch-2 supportive of the drug's effectiveness and/or
assuring on its long-term safety profile, the odds of
monotherapy approval have improved, Bernstein's Timothy Anderson
wrote in a client note.
Lilly said it would provide detailed data from the study at
a future medical conference, which analysts predict is likely at
the American Society of Clinical Oncology (ASCO) meeting in
Abemaciclib could steal a march over its rivals, should data
show a higher relative response rate and longer duration of
response, as well as good tolerability despite the frequent
diarrhea, Anderson added.
Bernstein's forecast of abemaciclib sales of $1.3 billion in
2021 assumes it would enter the market third with no real
differentiation, he said, noting if detailed data showed the
drug is more competitive, estimates would rise substantially.
After skin cancer, breast cancer is the most common cancer
in women in the United States, according to the U.S. Centers for
Disease Control and Prevention.
About 40,610 women will die from breast cancer in 2017, the
American Cancer Society estimates.
Lilly's shares were little changed at $84.68 in morning
(Reporting by Natalie Grover in Bengaluru; Editing by Sai
Sachin Ravikumar and Martina D'Couto)