TECENTRIQ

SAFETY PROFILE

Summary of overall safety profile for TECENTRIQ monotherapy and combination therapy1

Most common adverse reactions reported with TECENTRIQ1

Summary of adverse reactions occurring in patients treated with TECENTRIQ monotherapy in clinical trials2

Adverse drug reaction

TECENTRIQ (n=3178)

System Organ Class

All Grades (%)

Grade 3 - 4 (%)

Grade 5 (%)

Frequency (All Grades)

Blood and Lymphatic System Disorders

Thrombocytopenian

116 (3.7%)

27 (0.8%)

0 (0%)

Common

Cardiac Disorders

Myocarditisa

-

-

-

Rare

Endocrine Disorders

Hypothyroidismb

164 (5.2%)

6 (0.2%)

0 (0%)

Common

Hyperthyroidismc

30 (0.9%)

1 (<0.1%)

0 (0%)

Uncommon

Adrenal insufficiencyd

11 (0.3%)

2 (<0.1%)

0 (0%)

Uncommon

Hypophysitisy

2 (<0.1%)

0 (0%)

0 (0%)

Rare

Diabetes mellituse

10 (0.3%)

6 (0.2%)

0 (0%)

Uncommon

Gastrointestinal Disorders

Diarrhoeao

626 (19.7%)

36 (1.1%)

0 (0%)

Very Common

Dysphagia

82 (2.6%)

16 (0.5%)

0 (0%)

Common

Colitisf

34 (1.1%)

18 (0.6%)

0 (0%)

Common

Nausea

747 (23.5%)

35 (1.1%)

0 (0%)

Very Common

Vomiting

477 (15.0%)

26 (0.8%)

0 (0%)

Very Common

Abdominal pain

268 (8.4%)

34 (1.1%)

0 (0%)

Common

Pancreatitisg

18 (0.6%)

13 (0.4%)

0 (0%)

Uncommon

Oropharyngeal painq

131 (4.1%)

0 (0%)

0 (0%)

Common

General Disorders and Administration Site Conditions

Chills

207 (6.5%)

2 (<0.1%)

0 (0%)

Common

Fatigue

1142 (35.9%)

109 (3.4%)

0 (0%)

Very Common

Asthenia

461 (14.5%)

63 (2.0%)

0 (0%)

Very Common

Influenza like illness

186 (5.9%)

1 (<0.1%)

0 (0%)

Common

Pyrexia

638 (20.1%)

17 (0.5%)

0 (0%)

Very Common

Infusion related reactionh

34 (1.1%)

5 (0.2%)

0 (0%)

Common

Hepatobiliary Disorders

ALT increased

167 (5.3%)

46 (1.4%)

0 (0%)

Common

AST increased

180 (5.7%)

46 (1.4%)

0 (0%)

Common

Hepatitisi

62 (2.0%)

25 (0.8%)

2 (<0.1%)

Common

Immune System Disorders

Hypersensitivity

36 (1.1%)

3 (<0.1%)

0 (0%)

Common

Infections and Infestations

Urinary tract infectionp

368 (11.6%)

86 (2.7%)

0 (0%)

Very Common

Metabolism and Nutrition Disorders

Decreased appetite

810 (25.5%)

35 (1.1%)

0 (0%)

Very Common

Hypokalaemiav

142 (4.5%)

33 (1.0%)

0 (0%)

Common

Hyponatremiaw

171 (5.4%)

98 (3.1%)

0 (0%)

Common

Hyperglycaemia

103 (3.2%)

32 (1.0%)

0 (0%)

Common

Musculoskeletal and Connective Tissue Disorders

Arthralgia

441 (13.9%)

23 (0.7%)

0 (0%)

Very Common

Back pain 

487 (15.3%)

52 (1.6%)

0 (0%)

Very Common

Musculoskeletal painr

489 (15.4%)

36 (1.1%)

0 (0%)

Very Common

Myositist, u 

13 (0.4%)

5 (0.2%)

0

Uncommon

Nervous System Disorders

Headache

352 (11.1%)

10 (0.3%)

0 (0%)

Very Common

Guillain-Barré syndromej

5 (0.2%)

4 (0.1%)

0 (0%)

Uncommon

Meningoencephalitisk

14 (0.4%)

6 (0.2%)

0 (0%)

Uncommon

Myasthenic syndromez

1 (<0.1%)

0 (0%)

0 (0%)

Rare

Renal and Urinary Disorders

Blood creatinine increasedaa

171 (5.4%)

14 (0.4%)

0 (0%)

Common

Nephritiss 

3 (<0.1%)

1 (<0.1%)

0 (0%)

Rare

Respiratory, Thoracic, and Mediastinal Disorders

Cough 

660 (20.8%)

9 (0.3%)

0 (0%)

Very Common

Dyspnoea

651 (20.5%)

117 (3.7%)

1 (<0.1%)

Very Common

Hypoxiax

75 (2.4%)

36 (1.1%)

0 (0%)

Common

Nasal congestion

101 (3.2%)

0 (0%)

0 (0%)

Common

Pneumonitisl

87 (2.7%)

27 (0.8%)

1 (<0.1%)

Common

Nasopharyngitis

141 (4.4%)

0 (0%)

0 (0%)

Common

Skin and Subcutaneous Tissue Disorders

Rashm

619 (19.5%)

34 (1.1%)

1 (<0.1%)

Very Common

Pruritus

400 (12.6%)

7 (0.2%)

0 (0%)

Very Common

Dry Skin

187 (5.9%)

1 (<0.1%)

0 (0%)

Common

Vascular Disorders

Hypotension

102 (3.2%)

20 (0.6%)

0 (0%)

Common

No filter results

References for above table

a.  Reported in studies outside the pooled dataset. The frequency is based on the program-wide exposure.

b.  Includes reports of hypothyroidism, blood thyroid stimulating hormone increased, blood thyroid stimulating hormone decreased, thyroiditis, autoimmune hypothyroidism, euthyroid sick syndrome, myxoedema, thyroid function test abnormal, thyroiditis acute, thyroxine decreased

c.  Includes reports of hyperthyroidism, Basedow’s disease, endocrine ophthalmopathy, exophthalmos

d.  Includes reports of adrenal insufficiency, primary adrenal insufficiency

e.  Includes reports of diabetes mellitus, type 1 diabetes mellitus, diabetic ketoacidosis and ketoacidosis

f.   Includes reports of colitis, autoimmune colitis, colitis ischaemic, colitis microscopic, colitis ulcerative

g.  Includes reports of pancreatitis, autoimmune pancreatitis, pancreatitis acute, lipase increased and amylase increased

h.  includes infusion related reaction and cytokine release syndrome

i.  Includes reports of ascites, autoimmune hepatitis, hepatocellular injury, hepatitis, hepatitis acute, hepatotoxicity, liver disorder, drug-induced liver injury, hepatic failure, hepatic steatosis, hepatic lesion, oesophageal varices haemorrhage, varices oesophageal

j.  Includes reports of Guillain-Barré syndrome and demyelinating polyneuropathy

k.  Includes reports of encephalitis, meningitis, photophobia

l.   Includes reports of pneumonitis, lung infiltration, bronchiolitis, interstitial lung disease, radiation pneumonitis.

m.  Includes reports of rash, rash maculo-papular, erythema, rash pruritic, dermatitis acneiform, eczema, dermatitis, rash erythematous, skin ulcer, rash papular, folliculitis, rash macular, skin exfoliation, erythema multiforme, rash pustular, dermatitis bullous, furuncle, acne, drug eruption, palmar-plantar erythrodysaesthesia syndrome, seborrhoeic dermatitis, dermatitis allergic, rash generalised, erythema of eyelid, skin toxicity, toxic epidermal necrolysis, toxic skin eruption, dermatitis exfoliative generalised, exfoliative rash, eyelid rash, fixed eruption, generalised erythema, rash papulosquamous, rash vesicular

n.  Includes reports of thrombocytopenia and platelet count decreased

o.  Includes reports of diarrhoea, frequent bowel movements, and gastrointestinal hypermotility

p.  Includes reports of urinary tract infection, cystitis, pyelonephritis, Escherichia urinary tract infection, pyelonephritis acute, urinary tract infection bacterial, kidney infection, urinary tract infection fungal, urinary tract infection pseudomonal

q.  Includes reports of oropharyngeal pain, throat irritation, oropharyngeal discomfort

r.   Includes reports of musculoskeletal pain, myalgia, bone pain

s.  Includes reports of nephritis and Henoch-Schonlein Purpura nephritis

t.  Includes reports of myositis, rhabdomyolysis, polymyalgia rheumatica, dermatomyositis, muscle abscess, myoglobin urine present

u.  Fatal cases have been reported in studies outside the pooled dataset

v.  Includes reports of hypokalaemia and blood potassium decreased

w.  Includes reports of hyponatraemia and blood sodium decreased

x.  Includes reports of hypoxia, oxygen saturation decreased, PO2 decreased

y.  Includes reports of hypophysitis and temperature regulation disorder

z.  Includes report of myasthenia gravis

aa.  Includes reports of blood creatinine increased and hypercreatininaemia

Summary of adverse reactions occurring in patients treated with TECENTRIQ combination therapy in clinical trials2

Adverse drug reaction

TECENTRIQ + Combination Treatments (n = 4371)

System Organ Class

All Grades (%)

Grade 3-4 (%)

Grade 5 (%)

Frequency (All Grades)

Blood and Lymphatic System Disorders

Anaemia*

1608 (36.8%)

631 (14.4%)

0 (0%)

Very Common

Lymphopenia*k

145 (3.3%)

63 (1.4%)

0 (0%)

Common

Neutropenia*,a

1565 (35.8%)

1070 (24.5%)

6 (0.1%)

Very Common

Thrombocytopenia*,‡, b

1211 (27.7%)

479 (11.0%)

1 (<0.1%)

Very Common

Leukopenia*, i

571 (13.1%)

245 (5.6%)

0 (0%)

Very Common

Endocrine Disorders

Hypothyroidism*,‡,c

586 (13.4)

9 (0.2%)

0 (0%)

Very Common

Hyperthyroidism

193 (4.4%)

7 (0.2%)

0 (0%)

Common

Adrenal insufficiency‡,d

40 (0.9%)

8 (0.2%)

1 (<0.1%)

Uncommon

Hypophysitis‡,e

13 (0.3%)

5 (0.1%)

0 (0%)

Uncommon

Gastrointestinal Disorders

Constipation*

1123 (25.7%)

24 (0.5%)

0 (0%)

Very Common

Stomatitis*

351 (8.0%)

23 (0.5%)

0 (0%)

Common

General Disorders and Administration Site Conditions

Oedema Peripheral*

451 (10.3%)

11 (0.3%)

0 (0%)

Very Common

Infections and Infestations

Lung infection*h

564 (12.9%)

226 (5.2%)

26 (0.6%)

Very Common

Investigations

Blood alkaline phosphatase increased

200 (4.6%)

26 (0.6%)

0 (0%)

Common

Metabolism and Nutrition Disorders

Hypomagnesemia*j

403 (9.2%)

22 (0.5%)

0 (0%)

Common

Nervous System Disorders

Dizziness*

408 (9.3%)

9 (0.2%)

0 (0%)

Common

Dysgeusia*

269 (6.2%)

0 (0.0%)

0 (0%)

Common

Peripheral neuropathy*f

1007 (23.0%)

107 (2.4%)

0 (0%)

Very Common

Syncope*

68 (1.6%)

36 (0.8%)

0 (0%)

Common

Renal and Urinary Disorders

Nephritis‡, l

23 (0.5%)

15 (0.3%)

0 (0%)

Uncommon

Proteinuria*g

359 (8.2%)

61 (1.4%)

0 (0%)

Common

Respiratory, Thoracic and Mediastinal Disorders

Dysphonia*

236 (5.4%)

4 (< 0.1%)

0 (0%)

Common

Skin and Subcutaneous Tissue Disorders

Alopecian

1152 (26.4%)

3 (< 0.1%)

0 (0%)

Very Common

Vascular Disorders

Hypertension*m

611 (14.0%)

258 (5.9%)

0 (0%)

Very Common

No filter results

* ADR occurring at a frequency difference of ≥5% (All grades) or ≥2% (Grades 3-4) compared to the control arm‡  Observed rate in the combination represents a clinically relevant difference in comparison to TECENTRIQ monotherapy

References for above table

a. Includes reports of neutropenia, neutrophil count decreased, febrile neutropenia, neutropenic sepsis and, granulocytopenia

b. Includes reports of thrombocytopenia and platelet count decreased

c. Includes reports of hypothyroidism, blood thyroid stimulating hormone increased, blood thyroid stimulating hormone decreased, autoimmune thyroiditis, goitre, thyroiditis, thyroxine free decreased, tri−iodothyronine free decreased, thyroid disorder, thyroxine free increased, thyroxine increased, tri−iodothyronine decreased, tri-iodothyronine free increased, blood thyroid stimulating hormone abnormal, euthyroid sick syndrome, myxoedema coma, thyroid function test abnormal, thyroxine decreased, tri-iodothyronine abnormal, silent thyroiditis and thyroiditis chronic

d. Includes reports of adrenal insufficiency, cortisol decreased, adrenocortical insufficiency acute, secondary adrenocortical insufficiency, adrenocorticotropic hormone stimulation test abnormal, Addison's disease, adrenalitis and adrenocorticotropic hormone deficiency

e. Includes reports of hypophysitis and temperature regulation disorder

f. Includes reports of neuropathy peripheral, peripheral sensory neuropathy, polyneuropathy, herpes zoster, peripheral motor neuropathy, autoimmune neuropathy, neuralgic amyotrophy, peripheral sensorimotor neuropathy, axonal neuropathy, lumbosacral plexopathy, neuropathic arthropathy, toxic neuropathy and peripheral nerve infection

g. Includes reports of proteinuria, protein urine present, haemoglobinuria, and nephrotic syndrome, urine abnormality and albuminuria

h. Includes reports of pneumonia, bronchitis, lung infection, lower respiratory tract infection, tracheobronchitis, infective exacerbation of chronic obstructive airways disease, infectious pleural effusion, paracancerous pneumonia, atypical pneumonia, lung abscess, pleural infection and pyopneumothorax

i. Includes reports of white blood cell count decreased and leukopenia

j. Includes reports of hypomagnesaemia and blood magnesium decreased

k. Includes reports of lymphopenia and lymphocyte count decreased

l. Includes reports of nephritis, tubulointerstitial nephritis, autoimmune nephritis, nephritis allergic, glomerulonephritis, nephrotic syndrome and mesangioproliferative glomerulonephritis

m. Includes reports of hypertension, blood pressure increased, hypertensive crisis, blood pressure systolic increased, diastolic hypertension, blood pressure inadequately controlled and retinopathy hypertensive

n. Includes reports of alopecia, madarosis, alopecia areata, alopecia totalis and hypotrichosis

Safety profile for TECENTRIQ combination therapy with carboplatin/etoposide

The safety profile of atezolizumab plus carboplatin and etoposide was consistent with the previously reported safety profile of the individual agents, with no new findings observed.5

Safety profile for TECENTRIQ combination therapy with nab-paclitaxel 

Neutropenia and peripheral neuropathies occurring during treatment with atezolizumab and nab-paclitaxel may be reversible with interruptions of nab-paclitaxel.1 Physicians should consult the nab-paclitaxel summary of product characteristics for specific precautions and contraindications of this medicine.1

Adverse events were consistent with the known safety profiles of each agent, and those that led to the discontinuation of any agent occurred in 15.9% of the patients who received atezolizumab plus nab-paclitaxel and in 8.2% of those who received placebo plus nab-paclitaxel.6

Safety profile for TECENTRIQ combination therapy with bevacizumab + carboplatin/paclitaxel

Physicians should carefully consider the combined risks of the four-drug regimen of atezolizumab bevacizumab, paclitaxel, and carboplatin before initiating treatment.1

 

In the first-line NSCLC study (IMpower150), an overall higher frequency of adverse events was observed in the four-drug regimen of atezolizumab, bevacizumab, paclitaxel and carboplatin compared to atezolizumab, paclitaxel and carboplatin.7

  • Grade 3 and 4 events: 63.6% compared to 57.5%
  • Grade 5 events: 6.1% compared to 2.5%
  • Adverse events of special interest to atezolizumab: 52.4% compared to 48.0%
  • Adverse events leading to withdrawal of any study treatment: 33.8% compared to 13.3%

RESOURCES

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Connecting YOU WITH YOUR PATIENTS

CONNECTING YOU WITH YOUR PATIENTS

At Roche, we believe in a shared purpose in improving the care and treatment of patients living with difficult to treat cancers. We understand and empathise with the demands you face managing the needs of these patients.

Roche is committed to exploring new treatment options to individualise treatment and meet patients’ needs. TECENTRIQ has proven efficacy as monotherapy as well as in combination with other medicines and we are committed to exploring new combinations to improve patient outcomes (ref. SmPC). 

TECENTRIQ is an anti PD-L1 cancer immunotherapy that specifically targets PD-L1 on tumour and tumour-infiltrating immune cells across a broad range of solid tumours. TECENTRIQ offers a pioneering, targeted treatment with proven efficacy and an acceptable tolerability profile (ref. SmPC). Please see the specific indications for more information.

Connecting TECENTRIQ and COMBINATIONS

CONNECTING TECENTRIQ AND COMBINATIONS

TECENTRIQ has proven efficacy as monotherapy as well as in combination with other medicines and we are committed to explore new combinations for better patient outcomes (ref. SmPC).

In many difficult-to-treat tumour types with a high unmet need, including metastatic urothelial carcinoma, triple negative breast cancer and lung cancer (non-small cell lung cancer and small cell lung cancer), TECENTRIQ has shown significant improvements in progression-free and/or overall survival (ref. SmPC). Importantly, treatment can be tailored (i.e., in combination with the standard of care, or different dosing schedules) according to the type of cancer and the patient’s individual needs (ref. SmPC).
Read SmPC for more details

The multiple indications of TECENTRIQ (ref. SmPC)
provide a wealth of data to inform treatment decision-making and deliver valuable reassurance when considering the needs of your patients with cancer. Please see the specific indications for more information.

Connecting PATIENTS TO THEIR LOVED ONES

CONNECTING PATIENTS TO THEIR LOVED ONES

TECENTRIQ treatment offers the potential to improve treatment outcomes and maintain patient quality of life in your difficult to treat cancer patients, so they can hopefully spend more time with their loved ones.

TECENTRIQ is approved in metastatic urothelial carcinoma, non-small cell lung cancer, extensive-stage small cell lung cancer and triple negative breast cancer (ref. SmPC).

  • References & Notes

    References & Notes

    1 Tecentriq 1,200 mg concentrate for solution for infusion. Summary of Product Characteristics. Updated 10-Jun-2020 | Roche Products Limited. Available from: https://www.medicines.org.uk/ (Accessed September 2020).

     

    2 TECENTRIQ Core Data Sheet. Version 22. Roche. May 2020.08.26.

     

    3 Sternberg CN, et al. Primary results from SAUL, a multinational single-arm safety study of atezolizumab therapy for locally advanced or metastatic urothelial or nonurothelial carcinoma of the urinary tract. Eur Urol. 2019;76:73–81.

     

    4 Ardizzoni A, et al. Primary results from TAIL, a global single-arm safety study of atezolizumab (atezo) monotherapy in a diverse population of patients with previously treated advanced non-small cell lung cancer (NSCLC). Ann Oncol. 2019;30(Suppl 5):v920–1.

     

    5 Horn L, et al. IMpower133 Study Group. First-line atezolizumab plus chemotherapy in extensive-stage small-cell lung cancer. N Engl J Med. 2018;379:2220–9.

     

    6 Schmid P, et al; IMpassion130 Trial Investigators. Atezolizumab and nab-paclitaxel in advanced triple-negative breast cancer. N Engl J Med. 2018;379:2108–21.

     

    7 Socinski MA, et al; IMpower150 Study Group. Atezolizumab for first-line treatment of metastatic nonsquamous NSCLC. N Engl J Med. 2018;378:2288–301.