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    * How LUNSUMIO Is Thought to Work

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NOW APPROVED IN 3L+ FL


LUNSUMIO™: IMPRESSIVE PATIENT RESPONSES FROM THE FIRST-IN-CLASS FL T-CELL
ENGAGING BISPECIFIC ANTIBODY1

80% (n=72/90) of patients taking LUNSUMIO™ achieved ORR (95% CI: 70%, 88%).
Granted accelerated approval. Continued approval for this indication may be
contingent upon verification and description of clinical benefit in a
confirmatory trial(s).

Explore the clinical data

Actor portrayal.


NOW APPROVED IN 3L+ FL


LUNSUMIO™: IMPRESSIVE PATIENT RESPONSES FROM THE FIRST-IN-CLASS FL T-CELL
ENGAGING BISPECIFIC ANTIBODY1

80% (n=72/90) of patients taking LUNSUMIO™ achieved ORR (95% CI: 70%, 88%).
Granted accelerated approval. Continued approval for this indication may be
contingent upon verification and description of clinical benefit in a
confirmatory trial(s).

Explore the clinical data

Actor portrayal.


LUNSUMIO: THE FIRST-IN-CLASS FL T-CELL ENGAGING BISPECIFIC ANTIBODY1


Discover the Difference


SEE THE DOSING SCHEDULE FOR LUNSUMIO


Explore Dosing


GET INFORMATION ON IDENTIFYING CRS BASED ON CLINICAL PRESENTATION


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THERE ARE FINANCIAL ASSISTANCE OPTIONS FOR LUNSUMIO


Learn More

LUNSUMIO can be administered outpatient1

Hospitalization may be needed to manage select AEs, should be considered for
subsequent infusions following a Grade 2 CRS event, and is recommended for
subsequent infusions following a Grade 3 CRS event.

3L+=third-line or later; CRS=cytokine release syndrome; FL=follicular lymphoma.


IMPORTANT SAFETY INFORMATION & INDICATION

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INDICATION

LUNSUMIO (mosunetuzumab-axgb) is indicated for the treatment of adult patients
with relapsed or refractory follicular lymphoma after two or more lines of
systemic therapy.

This indication is approved under accelerated approval based on response.
Continued approval for this indication may be contingent upon verification and
description of clinical benefit in a confirmatory trial(s).

BOXED WARNING

Cytokine release syndrome (CRS), including serious or life-threatening
reactions, can occur in patients receiving LUNSUMIO. Initiate treatment with the
LUNSUMIO step-up dosing schedule to reduce the risk of CRS. Withhold LUNSUMIO
until CRS resolves or permanently discontinue based on severity.

Warnings and Precautions

Cytokine Release Syndrome (CRS)

LUNSUMIO can cause CRS, including serious or life-threatening reactions.

CRS occurred in 39% of patients who received LUNSUMIO at the recommended dose in
the clinical trial, with Grade 1 CRS occurring in 28%, Grade 2 in 15%, Grade 3
in 2%, and Grade 4 in 0.5% of patients. Recurrent CRS occurred in 11% of
patients. Most patients experienced CRS following doses of 1 mg on Cycle 1 Day 1
(15%), 2 mg on Cycle 1 Day 8 (5%), and 60 mg on Cycle 1 Day 15 (33%). Five
percent of patients experienced CRS after receiving 60 mg on Cycle 2 Day 1 with
1% of patients experiencing CRS following subsequent doses of LUNSUMIO.

The median time to onset of CRS from the start of administration in Cycle 1 Day
1 was 5 hours (range: 1 hour to 3 days), Cycle 1 Day 8 was 28 hours (range: 5
hours to 3 days), Cycle 1 Day 15 was 25 hours (range: 0.1 hours to 16 days), and
Cycle 2 Day 1 was 46 hours (range: 12 hours to 3 days). The median duration of
CRS was 3 days (range: 1 to 29 days).

Clinical signs and symptoms of CRS included, but were not limited to, fever,
chills, hypotension, tachycardia, hypoxia, and headache. Concurrent neurologic
adverse reactions occurred in 6% of patients and included, but were not limited
to, headache, confusional state, and anxiety. Initiate therapy according to
LUNSUMIO step-up dosing schedule to reduce the risk of CRS. Administer
pretreatment medications to reduce the risk of CRS, ensure adequate hydration,
and monitor patients following administration of LUNSUMIO accordingly.

At the first sign of CRS, immediately evaluate patients for hospitalization,
manage per current practice guidelines, and administer supportive care; withhold
or permanently discontinue LUNSUMIO based on severity.

Patients who experience CRS (or other adverse reactions that impair
consciousness) should be evaluated and advised not to drive and to refrain from
operating heavy or potentially dangerous machinery until resolution.

Neurologic Toxicity

LUNSUMIO can cause serious neurologic toxicity, including Immune Effector
Cell-Associated Neurotoxicity Syndrome (ICANS).

Neurologic toxicity occurred in 39% of patients who received LUNSUMIO at the
recommended dose in the clinical trial, with Grade 3 neurologic toxicity
occurring in 3% of patients. The most frequent neurologic toxicities were
headache (21%), peripheral neuropathy (13%), dizziness (11%), and mental status
changes (6%, including confusional state, disturbance in attention, cognitive
disorder, delirium, encephalopathy, and somnolence). ICANS was reported in 1% of
patients (Grade 1: 0.5%, Grade 2: 0.5%) who received LUNSUMIO at the recommended
dose in the clinical trial.

Coadministration of LUNSUMIO with other products that cause dizziness or mental
status changes may increase the risk of neurologic toxicity.

Monitor patients for signs and symptoms of neurologic toxicity during treatment.
At the first sign of neurologic toxicity, including ICANS, immediately evaluate
the patient, consider neurology evaluation as appropriate, and provide
supportive therapy based on severity; withhold or permanently discontinue
LUNSUMIO based on severity and follow management recommendations.

Patients who experience neurologic toxicity such as tremors, dizziness,
insomnia, severe neurotoxicity, or any other adverse reactions that impair
consciousness should be evaluated, including potential neurology evaluation, and
patients at increased risk should be advised not to drive and to refrain from
operating heavy or potentially dangerous machinery until resolution.

Infections

LUNSUMIO can cause serious or fatal infections. Among patients who received
LUNSUMIO at the recommended dose in the clinical trial, serious infections,
including opportunistic infections, occurred in 17%, with Grade 3 or 4
infections in 14%, and fatal infections in 0.9% of patients. The most common
Grade 3 or greater infections were pneumonia, sepsis, and upper respiratory
tract infection.

Monitor patients for signs and symptoms of infection prior to and during
treatment with LUNSUMIO and treat appropriately. LUNSUMIO should not be
administered in the presence of active infection. Caution should be exercised
when considering the use of LUNSUMIO in patients with a history of recurring or
chronic infections (e.g., chronic, active Epstein-Barr Virus), with underlying
conditions that may predispose to infections or who have had significant prior
immunosuppressive treatment. Administer prophylactic antimicrobials according to
guidelines. Withhold LUNSUMIO or consider permanent discontinuation of LUNSUMIO
based on severity.

Cytopenias

LUNSUMIO can cause serious or severe cytopenias, including neutropenia, anemia,
and thrombocytopenia. Among patients who received the recommended dosage in the
clinical trial, Grade 3 or 4 decreased neutrophils occurred in 38%, decreased
hemoglobin in 19%, and decreased platelets in 12% of patients. Grade 4 decreased
neutrophils occurred in 19% and decreased platelets in 5% of patients. Febrile
neutropenia occurred in 2%.

Monitor complete blood counts throughout treatment. Based on the severity of
cytopenias, temporarily withhold, or permanently discontinue LUNSUMIO. Consider
prophylactic granulocyte colony-stimulating factor administration as applicable.

Tumor Flare

LUNSUMIO can cause serious or severe tumor flare. Among patients who received
LUNSUMIO at the recommended dosage in the clinical trial, tumor flare occurred
in 4% of patients. Manifestations included new or worsening pleural effusions,
localized pain and swelling at the sites of lymphoma lesions, and tumor
inflammation.

Patients with bulky tumors or disease located in close proximity to airways or a
vital organ should be monitored closely during initial therapy. Monitor for
signs and symptoms of compression or obstruction due to mass effect secondary to
tumor flare. If compression or obstruction develops, institute standard
treatment of these complications.

Embryo-Fetal Toxicity

Based on its mechanism of action, LUNSUMIO may cause fetal harm when
administered to a pregnant woman. Advise pregnant women of the potential risk to
the fetus. Verify pregnancy status in females of reproductive potential prior to
initiating LUNSUMIO. Advise females of reproductive potential to use effective
contraception during treatment with LUNSUMIO and for 3 months after the last
dose.

Most Common Adverse Reactions

The most common (≥20%) adverse reactions were CRS (39%), fatigue (36%), rash
(34%), pyrexia (24%), and headache (21%).

The most common Grade 3 to 4 laboratory abnormalities (≥10%) were decreased
lymphocyte count (92%), decreased phosphate (41%), increased glucose (40%),
decreased neutrophil count (38%), increased uric acid (15%), decreased white
blood cell count (22%), decreased hemoglobin (19%), and decreased platelets
(12%).

Drug Interactions

LUNSUMIO causes release of cytokines that may suppress activity of CYP450
enzymes, resulting in increased exposure of CYP450 substrates. Increased
exposure of CYP450 substrates is more likely to occur after the first dose of
LUNSUMIO on Cycle 1 Day 1 and up to 14 days after the second 60 mg dose on Cycle
2 Day 1 and during and after CRS. Monitor for toxicity or concentrations of
drugs that are CYP450 substrates where minimal concentration changes may lead to
serious adverse reactions. Consult the concomitant CYP450 substrate drug
prescribing information for recommended dosage modification.

Use in Specific Populations

Lactation

There is no information regarding the presence of mosunetuzumab-axgb in human
milk, the effect on the breastfed child, or milk production. Because human IgG
is present in human milk, and there is potential for mosunetuzumab-axgb
absorption leading to B-cell depletion, advise women not to breastfeed during
treatment with LUNSUMIO for 3 months after the last dose.

You may report side effects to the FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch. You may also report side effects to Genentech
at 1-888-835-2555.

Please see the LUNSUMIO full Prescribing Information for additional Important
Safety Information, including BOXED WARNING.




Reference

 * * LUNSUMIO. Prescribing Information. Genentech, Inc.
     
     LUNSUMIO. Prescribing Information. Genentech, Inc.
   
   * FDA grants Breakthrough Therapy Designation for Roche’s CD20xCD3 bispecific
     cancer immunotherapy lunsumioetuzumab recognising its potential in
     follicular lymphoma. News release. July 14, 2020. Accessed December 17,
     2021. https://www.roche.com/investors/updates/inv-update-2020-07-14b.htm.
     
     FDA grants Breakthrough Therapy Designation for Roche’s CD20xCD3 bispecific
     cancer immunotherapy lunsumioetuzumab recognising its potential in
     follicular lymphoma. News release. July 14, 2020. Accessed December 17,
     2021. https://www.roche.com/investors/updates/inv-update-2020-07-14b.htm.
   
   * Budde LE, Sehn LH, Matasar M, et al. Safety and efficacy of mosunetuzumab,
     a bispecific antibody, in patients with relapsed or refractory follicular
     lymphoma: a single-arm, multicentre, phase 2 study. Lancet Oncol. Published
     online July 5, 2022. doi:10.1016/S1470-2045(22)00335-7.
     
     Budde LE, Sehn LH, Matasar M, et al. Safety and efficacy of mosunetuzumab,
     a bispecific antibody, in patients with relapsed or refractory follicular
     lymphoma: a single-arm, multicentre, phase 2 study. Lancet Oncol. Published
     online July 5, 2022. doi:10.1016/S1470-2045(22)00335-7.
   
   * Data on file. Genentech, Inc; 2022.
     
     Data on file. Genentech, Inc; 2022.

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