[Ip-health] Some background on non-profit and government funding of Ibrance's R&D

Jamie Love james.love at keionline.org
Wed Feb 4 12:07:31 PST 2015


Below is a 2012 UCLA article about PD 0332991, the drug now known as
Palbociclib, Pfizer trade name Ibrance, a cancer drug for HER2 negative
breast cancer patients that is priced by Pfizer at $118,200 per year.   It
includes this quote:

* "The core laboratory research for this project was funded primarily
through the Revlon/UCLA Women's Cancer Research Program and the longtime
philanthropic support of Ronald O. Perelman. Additional resources were
provided by a U.S.  Department of Defense Innovator Award
(W81XWH-05-1-0395) and the Noreen Frazier Foundation. The clinical trial
itself was supported entirely by Pfizer Inc."

The key scientific work was directed by Dr. Dennis Slamon, the same
scientist who relied upon Revlon funding to lead the development of
Herceptin, a Roche drug for HER2 positive breast cancer patients, a saga
described in moving detail in the movie, "Living Proof," and the
book: Her-2: The Making of Herceptin, a Revolutionary Treatment for Breast
Cancer.


http://newsroom.ucla.edu/releases/ucla-translational-researchers-241247


SCIENCE + TECHNOLOGY
Combination therapy with experimental drug improves outlook for breast
cancer patients
Shaun Mason | December 05, 2012

A combination therapy using an experimental new drug shows significant
promise for women with a common type of breast cancer in which estrogen
causes their tumors to grow, researchers with the Revlon/UCLA Women's
Cancer Research Program at UCLA's Jonsson Comprehensive Cancer Center
report.

The treatment, which incorporates the standard anti-estrogen therapy
letrozole and the experimental drug PD 0332991, developed by pharmaceutical
company Pfizer Inc., was found to increase progression-free survival time —
the length of time a patient is on treatment without tumor growth — in
women with estrogen receptor–positive, HER2-negative cancer, compared with
letrozole alone.

The results of a two-part, phase 2 clinical trial testing the new
combination therapy were announced Dec. 5 at the 2012 CTRC–AACR San Antonio
Breast Cancer Symposium in San Antonio, Texas, by Dr. Richard S. Finn, an
associate professor of medicine at UCLA and a member of the Jonsson Cancer
Center, who led the trial.

The clinical study built on pre-clinical work from the Translational
Oncology Research Laboratory directed by Dr. Dennis Slamon, a professor of
medicine at the Jonsson Cancer Center and director of the Revlon/UCLA
Women's Cancer Research Program.

For the first part of the study, in which 66 patients were enrolled,
preliminary results showed significant improvement in median
progression-free survival for individuals who were given the new drug
combination. The second part of the study enrolled 99 more patients — but
only those whose tumors revealed selected biomarkers known as CCND1
amplification and p16 loss.

Retrospective analysis from Part 1 of the suggested there was a clinical
benefit from PD 0332991 regardless of the women's biomarker status. All the
other demographic features of the patients were similar, so for final trial
analysis, the results of the study's two parts were combined for
presentation at the San Antonio Breast Cancer Symposium.

The researchers' analysis showed that the median progression-free survival
time for patients on the combination therapy was 26.1 months, compared with
7.5 months for those on letrozole alone. Of the patients with measurable
disease, 45 percent of those given the combination treatment had confirmed
responses, compared with 31 percent on letrozole alone.

And the clinical benefit rates — tumor shrinkage and/or stable disease for
a minimum of six months — were 70 percent with the combination therapy and
44 percent with only letrozole, the researchers report.

"This drug combination demonstrated a dramatic and clinically meaningful
effect on progression-free survival in women with estrogen
receptor–positive breast cancer," said Finn. "These results confirm the
pre-clinical work we began at the Translational Oncology Research
Laboratory."

Finn and his colleagues published their initial pre-clinical data in 2009,
which showed that PD 0332991 blocked two important proteins in cancer cells
— cyclin D kinase 4 (CDK 4) and cyclin D kinase 6 (CDK 6) — thus
prohibiting the growth of estrogen receptor–positive and HER2-amplified
cancer cells in the lab.

With the goal of identifying important targets for cancer therapy in the
lab and promptly developing them into patient treatments using the
translational paradigm, the investigators then conducted a phase 1 clinical
trial in collaboration with Pfizer in which the safety of the drug was
tested.

The results of that trial confirmed the safety of PD 0332991, which was
taken as a pill and was found to have manageable side effects. This
prompted the phase 2 trial comparing the combination of PD 0332991 and
letrozole to the standard treatment of letrozole alone.

Critical to the clinical studies were the synergistic interactions observed
in the laboratory between PD 0332991 and standard breast cancer drugs
tamoxifen and trastuzumab, which are used in treating estrogen
receptor–positive and HER2-positive breast cancers, respectively.

"The results of this phase 2 study validate the Translational Oncology
Research Laboratory approach," said Slamon, the study's senior author.

"By identifying these targets for treatment, we move forward with
personalized oncology that greatly improves the chances for this group of
patients," Slamon added. "These results are as exciting as the initial
results we saw for trastuzumab (Herceptin) in HER2-positive breast cancers
but represent a new approach for a different and larger subset of breast
cancers – those that are estrogen receptor–positive."

The core laboratory research for this project was funded primarily through
the Revlon/UCLA Women's Cancer Research Program and the longtime
philanthropic support of Ronald O. Perelman. Additional resources were
provided by a U.S.  Department of Defense Innovator Award
(W81XWH-05-1-0395) and the Noreen Frazier Foundation. The clinical trial
itself was supported entirely by Pfizer Inc.

 UCLA's Jonsson Comprehensive Cancer Center has more than 240 researchers
and clinicians engaged in disease research, prevention, detection, control,
treatment and education. One of the nation's largest comprehensive cancer
centers, the Jonsson Center is dedicated to promoting research and
translating basic science into leading-edge clinical studies. In July 2012,
the Jonsson Cancer Center was once again named among the nation's top 10
cancer centers by U.S. News & World Report, a ranking it has held for 12 of
the last 13 years.
​

-- 
James Love.  Knowledge Ecology International
http://www.keionline.org/donate.html
KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
+41.76.413.6584, twitter.com/jamie_love



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