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FDA Grants Genentech’s Polivy Accelerated Approval for People with Previously Treated Aggressive Lymphoma

June 10, 2019 Off By BusinessWire

– New targeted medicine shown to improve clinical outcomes in people
with relapsed or refractory diffuse large B-cell lymphoma compared to a
commonly used regimen –

– First-in-class antibody-drug conjugate that specifically targets
CD79b, a protein expressed in the majority of B-cells –

– Ninth indication with Breakthrough Therapy Designation in
Genentech’s hematology portfolio to receive FDA approval –

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY),
today announced that the U.S. Food and Drug Administration (FDA) has
granted accelerated approval to Polivy™ (polatuzumab vedotin-piiq) in
combination with bendamustine plus Rituxan^® (rituximab) (BR)
for the treatment of adults with relapsed or refractory (R/R) diffuse
large B-cell lymphoma (DLBCL), who have received at least two prior
therapies. Accelerated approval was granted for this indication based on
complete response rates observed in a randomized, controlled clinical
trial. The FDA’s Accelerated Approval Program allows conditional
approval of a medicine that fills an unmet medical need for a serious
condition. Continued approval for this indication may be contingent upon
verification and description of clinical benefit in a confirmatory trial.

“Despite meaningful progress in the treatment of diffuse large B-cell
lymphoma, treatment options are very limited when the disease is
refractory to or recurrent after multiple regimens,” said Sandra
Horning, M.D., chief medical officer and head of Global Product
Development. “Today’s approval of this Polivy combination will provide a
novel treatment that is both immediately available and very much needed
for people with this aggressive disease.”

“The approval of Polivy in combination with bendamustine and Rituxan
offers patients with relapsed or refractory diffuse large B-cell
lymphoma a new treatment option and new hope for improving patient
outcomes,” said Meghan Gutierrez, chief executive officer at the
Lymphoma Research Foundation. “New medicines can transform the way
healthcare providers approach this type of blood cancer and we commend
those who contribute to accelerating research for the benefit of
patients.”

The accelerated approval of Polivy was based on the results from the
Phase Ib/II GO29365 study. This is the first and only randomized pivotal
clinical trial to show higher response rates over BR, a commonly used
regimen, in people with R/R DLBCL who are ineligible for a hematopoietic
stem cell transplant. Results of the study showed that 40 percent of
people treated with Polivy plus BR achieved a complete response
(n=16/40; 95 percent CI: 25-57), meaning no cancer could be detected at
the time of assessment, compared to 18 percent with BR alone (n=7/40; 95
percent CI: 7-33). Complete response rates were assessed by independent
review committee. The study also showed that 45 percent of people on
Polivy plus BR achieved an objective response at the end of treatment
(n=18/40; 95 percent CI: 29-62), compared to 18 percent of people
treated with BR alone (n=7/40; 95 percent CI: 7-33). Of the people
treated with Polivy plus BR who achieved a complete or partial response,
64 percent (n=16/25) had a duration of response (DOR) lasting at least
six months as compared to 30 percent (n=3/10) of people treated with BR
alone. Additionally, 48 percent (n=12/25) of people treated with Polivy
plus BR had a DOR lasting at least a year as compared to 20 percent
(n=2/10) of people treated with BR alone. Adverse reactions occurring in
at least 20 percent of patients, and at least five percent more
frequently in patients treated with Polivy plus BR compared to BR alone,
included low white blood cell count, low platelet levels, low red blood
cell count, numbness, tingling or pain in the hands and feet, diarrhea,
fever, decreased appetite and pneumonia.

The FDA granted Priority Review for the company’s Biologics License
Application for Polivy in February 2019. Priority Review designation is
granted to medicines that the FDA considers to have the potential to
provide significant improvements in the safety and effectiveness of the
treatment, prevention or diagnosis of a serious disease. In addition,
Polivy was granted Breakthrough Therapy Designation by the FDA and PRIME
(PRIority MEdicines) designation by the European Medicines Agency for
the treatment of people with R/R DLBCL in 2017. Breakthrough Therapy
Designation is designed to expedite the development and review of
medicines intended to treat a serious condition with preliminary
evidence that indicates they may demonstrate substantial improvement
over existing therapies.

For those who qualify, Genentech will offer patient assistance programs
for people taking Polivy and Rituxan through Genentech Access Solutions.
Doctors can contact Genentech Access Solutions at (866) 422-2377. More
information is also available at http://www.Genentech-Access.com.

About the GO29365 study

GO29365 is a global, Phase Ib/II randomized study evaluating the safety,
tolerability and activity of Polivy (polatuzumab vedotin-piiq) in
combination with bendamustine and Rituxan (rituximab) (BR) or Gazyva
(obinutuzumab) in relapsed or refractory (R/R) follicular lymphoma or
diffuse large B-cell lymphoma (DLBCL). Eligible patients were not
candidates for hematopoietic stem cell transplant at study entry. The
Phase II part of the study randomized 80 patients with heavily
pre-treated R/R DLBCL to receive either BR, or BR in combination with
Polivy for a fixed duration of six 21-day cycles. Patients enrolled had
received a median of two prior therapies (a range of 1-7 prior therapies
in the Polivy arm and range of 1-5 prior therapies in the BR alone arm).
The primary endpoint was complete response (CR) at the end of treatment,
as measured by positron emission tomography and assessed by an
independent review committee (IRC). Secondary endpoints included overall
response rate (ORR; CR and partial response) by investigator assessment
and best ORR at the end of treatment by investigator and IRC assessment.
Exploratory endpoints included duration of response (DOR),
progression-free survival, event-free survival and overall survival.

About Polivy™ (polatuzumab vedotin-piiq)

Polivy is a first-in-class anti-CD79b antibody-drug conjugate (ADC). The
CD79b protein is expressed specifically in the majority of B-cells, an
immune cell impacted in some types of non-Hodgkin’s lymphoma (NHL),
making it a promising target for the development of new therapies.
Polivy binds to CD79b and destroys these B-cells through the delivery of
an anti-cancer agent, which is thought to minimize the effects on normal
cells. Polivy is being developed by Roche using Seattle Genetics ADC
technology and is currently being investigated for the treatment of
several types of NHL.

About DLBCL

Diffuse large B-cell lymphoma (DLBCL) is the most common form of
non-Hodgkin’s lymphoma (NHL), accounting for about one in three cases of
NHL. DLBCL is an aggressive (fast-growing) type of NHL, which is
generally responsive to treatment in the frontline. However, as many as
40 percent of patients will relapse, at which time salvage therapy
options are limited and survival is short. In the United States, it is
estimated that nearly 25,000 new cases of DLBCL will be diagnosed in
2019.

Polivy U.S. Indication

Polivy is a prescription medicine used with other medicines,
bendamustine and a rituximab product, to treat diffuse large B-cell
lymphoma in adults who have had at least two prior therapies.

The approval of Polivy is based on a type of response rate. There is an
ongoing study to confirm the clinical benefit of Polivy.

Important Safety Information

Possible serious side effects

Everyone reacts differently to Polivy therapy, so it’s important to know
what the side effects are. Some people who have been treated with
Polivy have experienced serious to fatal side effects. A patient’s
doctor may stop or adjust a patient’s treatment if any serious side
effects occur. Patients must contact their healthcare team if there
are any signs of these side effects.

Infections: Patients should contact their healthcare team, if
they experience a fever of 100.4°F or higher, chills, cough, or pain
during urination. Also, a patient’s doctor may give medication, which
may prevent some infections, before giving Polivy and monitor blood
counts throughout treatment with Polivy
Infusion-related reactions: A patient may experience fever,
chills, rash, or breathing problems within 24 hours of the infusion
Nerve problems in arms and legs: This may happen as early as
after the first dose and may worsen with every dose. If a patient
already has nerve pain, Polivy may make it worse. The patient’s doctor
will monitor for signs and symptoms, such as numbness and tingling
Rare and serious brain infections: A patient’s doctor will
monitor the patient closely for signs and symptoms of these types of
infections. Patients should contact their doctor if they experience
confusion, dizziness or loss of balance, trouble talking or walking,
or vision changes
Tumor lysis syndrome: Caused by the fast breakdown of cancer
cells. Signs include nausea, vomiting, diarrhea, and lack of energy
Potential harm to liver: Some signs include tiredness,
weight loss, pain in the abdomen, dark urine, and yellowing of the
skin or the white part of the eyes. Patients may be at higher risk if
they already have liver problems or are taking other medication

Side effects seen most often

The most common side effects during treatment were

Low blood cell counts (platelets, red blood cells, white blood cells)
Nerve problems in arms and legs
Tiredness or lack of energy
Diarrhea
Nausea
Fever
Decreased appetite
Infections

Polivy may not be for everyone. A patient should talk to their doctor
if they are

Pregnant or may be pregnant: Data have shown that Polivy may
harm an unborn baby
Planning to become pregnant: Women should avoid getting
pregnant while taking Polivy. Women should use effective contraception
during treatment and for at least 3 months after their last Polivy
treatment. Men taking Polivy should use effective contraception during
treatment and for at least 5 months after their last Polivy treatment
Breastfeeding: Women should not breastfeed while taking Polivy
and for 2 months after the last dose

These may not be all the side effects. Patients should talk to their
healthcare provider for more information about the benefits and risks of
Polivy treatment.

Report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch.
Report side effects to Genentech at (888) 835-2555.

Please visit http://www.Polivy.com
for the full Prescribing Information for additional Important Safety
Information.

About Genentech in Hematology

For more than 20 years, Genentech has been developing medicines with the
goal to redefine treatment in hematology. Today, we’re investing more
than ever in our effort to bring innovative treatment options to people
with diseases of the blood. Genentech now has five approved medicines in
our broader hematology portfolio. For more information visit http://www.gene.com/hematology.

About Genentech

Founded more than 40 years ago, Genentech is a leading biotechnology
company that discovers, develops, manufactures and commercializes
medicines to treat patients with serious and life-threatening medical
conditions. The company, a member of the Roche Group, has headquarters
in South San Francisco, California. For additional information about the
company, please visit http://www.gene.com.