Sugemalimab

The use of systemic corticosteroids or immunosuppressants before starting sugemalimab should be avoided because of their potential interference with the pharmacodynamic activity and efficacy of sugemalimab. However, systemic corticosteroids or other immunosuppressants can be used after starting sugemalimab to treat immune-related adverse reactions.

Sugemalimab has not been studied in patients with severe renal impairment. Sugemalimab must be administered with caution in patients with severe renal impairments.

Sugemalimab has not been studied in patients with moderate or severe hepatic impairment. Sugemalimab must be administered with caution in patients with moderate or severe hepatic impairment.

There are no data on the use of sugemalimab in pregnant women. Animal reproduction and developmental toxicity studies have not been conducted with sugemalimab. However, blockade of PD-L1 signalling in murine models of pregnancy has been shown to disrupt tolerance to the foetus and to increase foetal loss.

Sugemalimab is not recommended during pregnancy and in women of childbearing potential not using contraception.

It is unknown whether sugemalimab is secreted in human milk. Since it is known that antibodies can be secreted in human milk, a risk to the newborns/infants cannot be excluded. A decision should be made whether to discontinue breast-feeding or to discontinue sugemalimab treatment, taking into account the benefit of breast-feeding for the child and the benefit of sugemalimab therapy for the woman.

Women of childbearing potential/Contraception in females

Women of childbearing potential must be advised to avoid pregnancy during treatment with sugemalimab. Women of childbearing potential receiving sugemalimab should use reliable contraception methods during treatment and for at least 4 months after the last dose of sugemalimab.

Fertility

No clinical data are available on the possible effects of sugemalimab on fertility. Animal data did not show notable effects on the male and female reproductive organs.

Sugemalimab has minor influence on the ability to drive and use machines. In some patients, fatigue has been reported following administration of sugemalimab. Patients experiencing fatigue should be advised not to drive and use machines until the symptoms resolved.

Summary of the safety profile

The safety of sugemalimab has been evaluated in 1003 patients receiving 1200 mg every 3 weeks in clinical studies across tumour types. 435 out of those 1003 patients received sugemalimab in combination with chemotherapy, and 568 out of those 1003 patients received sugemalimab as monotherapy.

The incidence of adverse reactions in patients treated in combination with chemotherapy was 95.6%. The most common adverse reactions (≥10%) were anaemia (77.5%), hepatic enzyme increased (42.5%), rash (26.2%), hyperlipidaemia (21.6%), hyperglycaemia (18.4%), hyponatraemia (16.8%), hypokalaemia (15.6%), hypothyroidism (15.6%), hyperthyroidism (15.2%), proteinuria (14.0%), abdominal pain (13.8%), fatigue (13.3%), arthralgia (12.2%), hypoaesthesia (11.5%) and hypocalcaemia (10.1%). The incidence of Grade ≥ 3 adverse reactions in these patients was 33.1%. The most common Grade ≥ 3 adverse reactions (>1%) were anaemia (17.5%), hyponatraemia (4.4%), hypokalaemia (3.0%), hyperlipidaemia (2.3%), hepatic enzyme increased (2.3%), amylase increased (2.1%), hepatic function abnormal (1.8%), hyperglycaemia (1.6%), fatigue (1.4%), rash (1.4%), hypertension (1.4%) and pneumonitis (1.1%).

The incidence of adverse reactions in patient treated with monotherapy was 81.5%. The most common adverse reactions (≥10%) were hepatic enzyme increased (28.3%), anaemia (22.9%), hypothyroidism (22.5%), rash (17.1%), pyrexia (15.3%), hyperthyroidism (14.4%), blood bilirubin increased (13.0%), hyperlipidaemia (12.9%), proteinuria (12.3%) and hyperglycaemia (10.9%). The incidence of Grade ≥ 3 adverse reactions in these patients was 16.7%. The most common Grade ≥ 3 adverse reactions (> 1%) were anaemia (3.2%), hepatic enzyme increased (3.0%), blood bilirubin increased (1.8%), hypertension (1.6%), hypokalaemia (1.4%), hyponatraemia (1.4%), rash (1.2%) and hyperlipidaemia (1.2%).

Tabulated list of adverse reactions

Adverse drug reactions observed in clinical studies of sugemalimab in combination with chemotherapy and sugemalimab as monotherapy are listed in the table below. These reactions are presented by system organ class and by frequency. Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1 000 to <1/100); rare (≥1/10 000 to <1/1 000) and very rare (<1/10 000). Within each frequency grouping, adverse reactions are presented in the order of decreasing frequency.

Adverse reactions:

^* Grouped terms which refer to a class effect of immune-related adverse reaction. In clinical studies of sugemalimab in monotherapy or combination with chemotherapy, only myelosuppression, blood corticotrophin decreased, and neuritis were observed respectively under immune-related pancytopenia/bicytopenia, hypophysitis, and Guillain-Barre syndrome/demyelination.
^# The ADR can be immune-related adverse reaction.
The following terms represent a group of related events that describe a medical condition rather than a single event:
^a Hypothyroidism (hypothyroidism, blood thyroid stimulating hormone increased, thyroxine free decreased, tri-iodothyronine free decreased)
^b Hyperthyroidism (hyperthyroidism, blood thyroid stimulating hormone decreased, thyroxine increased, thyroxine free increased, tri-iodothyronine free increased)
^c Hyperlipidaemia (hyperlipidaemia, hypercholesterolaemia, hypertriglyceridaemia, blood triglycerides increased, blood cholesterol increased)
^d Hyperglycaemia (hyperglycaemia, blood glucose increased)
^e Hypocalcaemia (hypocalcaemia, blood calcium decreased)
^f Hyperuricaemia (hyperuricaemia, blood uric acid increased)
^g Hypochloraemia (hypochloraemia, blood chloride decreased)
^h Hypoaesthesia (hypoaesthesia, anaesthesia)
ⁱ Tachycardia (tachycardia, sinus tachycardia, supraventricular tachycardia, atrial tachycardia, atrial fibrillation, ventricular fibrillation)
^j Myocarditis (myocarditis, immune-mediated myocarditis)
^k Pneumonitis (pneumonitis, immune-mediated lung disease, interstitial lung disease)
^l Abdominal pain (abdominal pain, abdominal discomfort, abdominal distension, abdominal pain upper)
^m Stomatitis (stomatitis, mouth ulceration)
ⁿ Hepatic enzyme increased (alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, gamma-glutamyltransferase increased, transaminases increased)
° Blood bilirubin increased (blood bilirubin unconjugated increased, bilirubin conjugated increased, blood bilirubin increased)
^p Hepatitis (hepatitis, immune-mediated hepatic disorder, immune-mediated hepatitis, drug-induced liver injury, hepatic failure)
^q Rash (rash, rash maculo-papular, eczema, erythema, dermatitis, dermatitis acneiform, rash erythematous, rash pruritic, urticaria, pruritus, immune-mediated dermatitis, papule, drug eruption)
^r Skin hypopigmentation (skin hypopigmentation, skin depigmentation, leukoderma)
^s Myositis (myositis, immune-mediated myositis)
^t Proteinuria (proteinuria, protein urine present)
^u Nephritis (nephritis, renal impairment, renal injury, renal failure, acute kidney injury)
^v Blood creatine phosphokinase increased (blood creatine phosphokinase increased, blood creatine phosphokinase MB increased)

Description of selected adverse reactions

Data for the following immune-related adverse reactions are based on information from 1003 patients, of whom 435 patients were treated with sugemalimab in combination with chemotherapy and 568 patients were treated with sugemalimab monotherapy in clinical studies.

Immune-related adverse reactions

Immune-related hypothyroidism

Immune-related hypothyroidism was reported in 14.3% of patients treated with sugemalimab in combination with chemotherapy. The majority of events were Grade 1 or 2 in severity reported in 9.2% and 4.8% of patients, respectively. Grade 3 hypothyroidism was reported in 0.2% of patients. No serious hypothyroidism was reported. Events led to treatment interruption and discontinuation were reported in 0.9% and 0.2% of patients, respectively. The median time to onset was 112 days (range: 16 to 607 days), and the median duration was 83 days (range: 1+ to 857+ days).

Immune-related hypothyroidism was reported in 16.7% of patients treated with sugemalimab monotherapy. The majority of events were Grade 1 or 2 in severity reported in 10.9% and 5.1% of patients, respectively. Grade 3 hypothyroidism was reported in 0.7% of patients. No serious hypothyroidism was reported. Events led to treatment interruption and discontinuation were reported in 1.6% and 0.2% of patients, respectively. The median time to onset was 92 days (range: 20 to 683 days), and the median duration was 125 days (range: 2+ to 979+ days).

Immune-related hyperthyroidism

Immune-related hyperthyroidism was reported in 9.4% of patients treated with sugemalimab in combination with chemotherapy. All events were Grade 1 and 2 in severity reported in 8.7% and 0.7% of patients, respectively. There were no serious events, or events led to treatment interruption or discontinuation. The median time to onset was 91 days (range: 20 to 620 days), and the median duration was 44 days (range: 10 to 484+ days).

Immune-related hyperthyroidism was reported in 11.3% of patients treated with sugemalimab monotherapy. The majority of events were Grade 1 or 2 in severity reported in 9.0% and 2.1% of patients, respectively. Grade 3 hyperthyroidism was reported in 0.2% of patients. There were no serious events, or events led to treatment discontinuation. Events led to treatment interruption were reported in 0.4% of patients. The median time to onset was 44.5 days (range: 20 to 692 days), and the median duration was 43 days (range: 9 to 1000+ days).

Immune-related thyroiditis

Immune-related thyroiditis was reported in 0.5% of patients treated with sugemalimab in combination with chemotherapy. All events were Grade 1 in severity. There were no serious events, or events led to treatment interruption or discontinuation. The median time to onset was 136 days (range: 105 to 167 days), and the median duration was not reached (range: 736+ to 835+ days). Immune-related thyroiditis was reported in 0.5% of patients treated with sugemalimab monotherapy.

All events were Grade 1 and 2 in severity reported in 0.4% and 0.2% of patients, respectively. There were no serious events, or events led to treatment discontinuation. Events led to treatment interruption were reported in 0.2% of patients. The median time to onset was 42 days (range: 40 to 104 days), and the median duration was 122.5 days (range: 22 to 616+ days).

Diabetes mellitus

Immune-related diabetes mellitus was reported in 2.8% of patients treated with sugemalimab in combination with chemotherapy. The majority of events were Grade 1 in severity reported in 2.3% of patients. Grade 2 and Grade 3 events were reported in 0.2% of patients, respectively. There were no serious events, or events led to treatment interruption or discontinuation. The median time to onset was 154 days (range: 43 to 635 days), and the median duration was 41 days (range: 2 to 307+ days). Immune-related diabetes mellitus was reported in 2.3% of patients treated with sugemalimab monotherapy. The majority of events were Grade 1 and 2 in severity reported in 1.8% and 0.4% of patients, respectively. Grade 3 events were reported in 0.2% of patients. There were no serious events, or events led to treatment interruption or discontinuation. The median time to onset was 101 days (range: 20 to 454 days), and the median duration was 43 days (range: 1 to 911+ days).

Immune-related hypophysitis

Immune-related hypophysitis was reported in 0.9% of patients treated with sugemalimab in combination with chemotherapy. All events were Grade 1 in severity. There were no serious events, or events leading to treatment interruption or discontinuation. The median time to onset was 240.5 days (range: 112 to 754 days), and the median duration was not reached (range: 13+ to 478+ days).

Immune-related hypophysitis was reported in 0.4% of patients treated with sugemalimab monotherapy. All events were Grade 1 in severity. There were no serious events, or events leading to treatment interruption or discontinuation. The median time to onset was 168 days (range: 42 to 294 days), and the median duration was 22 days (range: 22 to 22 days).

Immune-related adrenal insufficiency

Immune-related adrenal insufficiency was reported in 0.2% of patients treated with sugemalimab in combination with chemotherapy. The event occurred in a single patient, was Grade 1 in severity, and did not lead to treatment interruption nor discontinuation.

Immune-related adrenal insufficiency was reported in 0.2% of patients treated with sugemalimab monotherapy. The event occurred in a single patient, was Grade 1 in severity, and did not lead to treatment interruption nor discontinuation.

Immune-related skin adverse reactions

Immune-related skin adverse reactions (excluding severe) were reported in 10.6% of patients treated with sugemalimab in combination with chemotherapy. All events were Grade 1 and 2 in severity and were reported in 7.1% and 3.4% of patients, respectively. Immune-related skin adverse reaction (excluding severe) leading to treatment interruption were reported in 0.9% of patients. There were no serious events or events leading to treatment discontinuation. The median time to onset was 158 days (range: 3 to 990 days), and the median duration was 31 days (range: 1 to 950+ days).

Immune-related skin adverse reactions (excluding severe) were reported in 9.2% of patients treated with sugemalimab monotherapy. All events were Grade 1 and 2 in severity and were reported in 6.9% and 2.3% of patients, respectively. None of the events were serious or led to treatment interruption or discontinuation. The median time to onset was 53 days (range: 5 to 441 days), and the median duration was 77 days (range: 2 to 646+ days).

Immune-related severe skin adverse reaction was reported in 1.6% of patients treated with sugemalimab in combination with chemotherapy. Serious events were reported in 0.5% of patients, events leading to treatment interruption were reported in 0.9% of patients, and events leading to treatment discontinuation were reported in 0.5% of patients. The median time to onset was 312 days (range: 19 to 738 days), and the median duration was 95 days (range: 12 to 522+ days).

Immune-related severe skin adverse reaction was reported in 1.1% of patients treated with sugemalimab monotherapy. All events were Grade 3. None of the events were serious. Events leading to treatment interruption were reported in 0.7% of patients, and events leading to treatment discontinuation were reported in 0.2% of patients. The median time to onset was 13 days (range: 3 to 138 days), and the median duration was 285 days (range: 41 to 342+ days).

Immune-related hepatitis

Immune-related hepatitis was reported in 9.7% of patients treated with sugemalimab in combination with chemotherapy. Grade 1, 2, 3 and 4 events were reported in 5.7%, 1.4%, 2.3% and 0.2% of patients, respectively. Serious events were reported in 2.5% of patients. Events leading to treatment interruption and discontinuation were reported in 2.3% and 1.6% of patients, respectively. The median time to onset was 53 days (range: 1 to 717 days), and the median duration was 25 days (range: 2 to 777+ days).

Immune-related hepatitis was reported in 8.1% of patients treated with sugemalimab monotherapy.Grade 3,4 and 5 events were reported in 0.7%, 0.2%, and 0.2% of patients. Serious events were reported in 0.7% of patients. Events leading to treatment interruption and discontinuation were reported in 0.9% and 0.4% of patients, respectively. The median time to onset was 86.5 days (range: 20 to 509 days), and the median duration was 31 days (range: 5 to 470+ days).

Immune-related pancreatitis

Immune-related pancreatitis was reported in 3.4% of patients treated with sugemalimab in combination with chemotherapy. Grade 1, 2, 3 and 4 events were reported in 1.6%, 0.7%, 0.9% and 0.2% of patients, respectively. Serious events were reported in 0.2% of patients. Events leading to treatment interruption were reported in 0.5% of patients. No events leading to treatment discontinuation were reported. The median time to onset was 42 days (range: 20 to 629 days), and the median duration was 53 days (range: 2 to 958+ days).

Immune-related pancreatitis was reported in 1.2% of patients treated with sugemalimab monotherapy. The majority of events were Grade 1 or 2 in severity reported in 0.9% and 0.2% of patients, respectively. None of the events were serious or leading to treatment discontinuation. Events leading to dose interruption were reported in 0.2% of patients. The median time to onset was 42 days (range: 20 to 642 days), and the median duration was not reached (range: 22 to 979+ days).

Immune-related pneumonitis

Immune-related pneumonitis was reported in 3.0% of patients treated with sugemalimab in combination with chemotherapy. Grade 1, 2, 3 and 5 events were reported in 0.2%, 1.6%, 0.9% and 0.2% of patients, respectively. Serious events were reported in 2.1% of patients. Events led to treatment interruption and discontinuation were reported in 1.1% and 1.8% of patients, respectively. The median time to onset was 165 days (range: 6 to 903 days), and the median duration was 229 days (range: 18 to 558+ days).

Immune-related pneumonitis was reported in 9.3% of patients treated with sugemalimab monotherapy. Grade 1, 2, 3, 4 and 5 events were reported in 1.8%, 6.0%, 0.9%, 0.4% and 0.4% of patients, respectively. Serious events were reported in 4.8% of patients. Events leading to treatment interruption and discontinuation were reported in 4.0% and 3.0% of patients, respectively. The median time to onset was 63 days (range: 1 to 490 days), and the median duration was 556 days (range: 2 to 845+ days).

Immune-related pneumonitis occurred more frequently in patients in the Study GEMSTONE-301 who had completed treatment with concurrent or sequential chemoradiation within 1 to 42 days prior to initiation of study treatment (21.6%), than in the other patients in the monotherapy (1.3%).

In Study GEMSTONE-301 (n=255 in the sugemalimab group), immune- related pneumonitis occurred in 55 (21.6%) patients. Grade 1, 2, 3,4 and 5 events were reported in 3.1%, 14.9%, 2.4%, 0.8% and 0.4% of patients, respectively. Serious events were reported in 12.5% of patients. Events leading to treatment interruption and discontinuation were reported in 8.6% and 8.2% of patients, respectively. The median time to onset was 63 days (range: 1 to 784 days), and the median duration was not estimable (range: 9 to 1601 days).

Immune-related myositis

Immune-related myositis was reported in 2.5% of patients treated with sugemalimab in combination with chemotherapy. All events were Grade 1 and 2 in severity and were reported in 0.9% and 1.6% of patients, respectively. Events led to treatment interruption were reported in 0.2% of patients. There were no serious events or events that led to treatment discontinuation. The median time to onset was 135 days (range: 3 to 649 days), and the median duration was 42 days (range: 2 to 655+ days).

Immune-related myositis was reported in 2.3% of patients treated with sugemalimab monotherapy. The majority of events were Grade 1 or 2 in severity reported in 1.2% and 0.9% of patients, respectively. Serious events were reported in 0.7% of patients. Events led to treatment interruption and discontinuation were reported in 0.2% and 0.5% of patients. The median time to onset was 64 days (range: 20 to 323 days), and the median duration was 71 days (range: 8 to 772+ days).

Immune-related colitis

Immune-related colitis was reported in 2.5% of patients treated with sugemalimab in combination with chemotherapy. All events were Grade 1 and 2 in severity and were reported in 1.1% and 1.4% of patients, respectively. Events leading to treatment interruption were reported in 0.2% of patients. No serious events or events leading to treatment discontinuation were reported. The median time to onset was 103 days (range: 1 to 682 days), and the median duration was 9 days (range: 2 to 445+ days).

Immune-related colitis was reported in 1.4% of patients treated with sugemalimab monotherapy. Grade 1 ,2 and 4 events were reported in 0.7%,0.5% and 0.2% of patients, respectively. Serious events were reported in 0.4% of patients. Events leading to treatment interruption were reported in 0.2% of patients. No events leading to treatment discontinuation were reported. The median time to onset was 43.5 days (range: 2 to 637 days), and the median duration was 11 days (range: 2 to 101+ days).

Immune-related myocarditis

Immune-related myocarditis was reported in 2.1% of patients treated with sugemalimab in combination with chemotherapy. All events were Grade 1 and 2 in severity and were reported in 1.1% and 0.9% of patients, respectively. Serious events were reported in 0.7% of patients. Events leading to treatment interruption and discontinuation were reported in 1.1% and 0.2% of patients, respectively. The median time to onset was 221 days (range: 41 to 442 days), and the median duration was 23 days (range: 1 to 429+ days).

Immune-related myocarditis was reported in 2.8% of patients treated with sugemalimab monotherapy. All events were Grade 1 and 2 in severity and were reported in 2.1% and 0.7% of patients, respectively. Serious events were reported in 0.7% of patients. Events leading to treatment interruption and discontinuation were reported in 0.5% and 0.2% of patients, respectively. The median time to onset was 84 days (range: 21 to 505 days), and the median duration was not reached (range: 1 to 849+ days).

Immune-related nephritis

Immune-related nephritis (including renal failure) was reported in 1.8% of patients treated with sugemalimab in combination with chemotherapy. Grade 1, 2 and 3 events were reported in 0.9%, 0.2% and 0.7% of patients, respectively. Serious events were reported in 0.9% of patients. Events leading to treatment interruption and discontinuation were reported in 0.5% and 0.2% of patients, respectively. The median time to onset was 227.5 days (range: 26 to 539 days), and the median duration was 51.5 days (range: 5 to 543+ days).

Immune-related nephritis (including renal failure) was reported in 1.2% of patients treated with sugemalimab monotherapy. All events were Grade 1 or 2 patients in severity and were reported in 1.1% and 0.2% of patients, respectively. Events leading to dose interruption were reported in 0.2% of patients. None of the events were serious or led to treatment discontinuation. The median time to onset was 197 days (range: 42 to 446 days), and the median duration was 22 days (range: 6 to 570+ days).

Immune-related ocular toxicities

Immune-related ocular toxicities were reported in 1.4% of patients treated with sugemalimab in combination with chemotherapy. All events were Grade 1 and 2 in severity and were reported in 0.7% and 0.7%, respectively. No serious events were reported. Events leading to treatment interruption and discontinuation were reported in 0.5% and 0.2% of patients, respectively. The median time to onset was 235.5 days (range: 137 to 482 days), and the median duration was 9.5 days (range: 1 to 181 days).

Immune-related ocular toxicities were reported in 0.2% of patients treated with sugemalimab monotherapy. The event occurred in a single patient, was Grade 2 in severity and led to treatment interruption.

Immune-related upper gastrointestinal disorders

Immune-related upper gastrointestinal disorder was reported in 0.9% of patients treated with sugemalimab in combination with chemotherapy. Grade 1, 2 and 3 events were reported in 0.5%, 0.2% and 0.2% of patients, respectively. Serious events were reported in 0.2% of patients. No events leading to treatment interruption or discontinuation were reported. The median time to onset was 146 days (range: 82 to 204 days), and the median duration was 385 days (range: 42 to 710 days).

Immune-related upper gastrointestinal disorder was reported in 0.5% of patients treated with sugemalimab monotherapy. All events were Grade 1 in severity. None of the events were serious or led to treatment interruption or discontinuation. The median time to onset was 5 days (range: 2 to 178 days), and the median duration was 8 days (range: 7 to 154 days).

Immune-related arthritis

Immune-related arthritis was reported in 0.9% of patients treated with sugemalimab in combination with chemotherapy. All events were Grade 1 and 2 in severity and were reported in 0.2% and 0.7% of patients, respectively. No serious events were reported. Events leading to treatment interruption were reported in 0.5% of patients. No events led to treatment discontinuation were reported. The median time to the onset was 173.5 days (range: 96 to 257 days), and the median duration was 98 days (range: 50 to 958+ days).

Immune-related arthritis was reported in 0.2% of patients treated with sugemalimab monotherapy. This event was occurred in a single patient, was of Grade 2 in severity. The event was not serious and did not lead to treatment interruption or discontinuation.

Immune-related pancytopenia/bicytopenia

Immune-related pancytopenia/bicytopenia was reported in 0.2% of patients treated with sugemalimab in combination with chemotherapy. The event occurred in a single patient, was Grade 4 in severity and serious, and did not lead to treatment interruption or discontinuation.

Immune-related pancytopenia/bicytopenia was reported in 0.4% of patients treated with monotherapy. All events were ≥ Grade 3 and serious. Events leading to treatment discontinuation were reported in 0.2% of patients. The median time to the onset of the first event was 109.5 days (range: 106 to 113 days), and the median duration was not reached (57+ to 239+ days).

Immune-related meningoencephalitis/encephalitis

Immune-related meningoencephalitis/encephalitis was reported in 0.2% of patients treated with sugemalimab in combination with chemotherapy. The event occurred in a single patient, was of Grade 2 in severity and led to treatment discontinuation.

No event of immune-related meningoencephalitis/encephalitis was reported in patients treated with sugemalimab monotherapy.

Immune-related Guillain-Barre syndrome/demyelination

Immune-related Guillain-Barre syndrome/demyelination was reported in 0.2% of patients treated with sugemalimab in combination with chemotherapy. The event occurred in a single patient, was of Grade 2 in severity and serious, and did not lead to treatment interruption or discontinuation.

No event of immune-related Guillain-Barre syndrome/demyelination was reported in patients treated with sugemalimab monotherapy.

Immune-related rhabdomyolysis/myopathy

Immune-related rhabdomyolysis/myopathy was reported in 0.2% of patients treated with sugemalimab in combination with chemotherapy. The event occurred in a single patient, was of with Grade 2 in severity and led to treatment interruption.

Immune-related rhabdomyolysis/myopathy was reported in 0.2% of patients treated with sugemalimab monotherapy. The event occurred in a single patient, was of Grade 1 in severity. The event was not serious and did not lead to treatment interruption or discontinuation.

Immune-related hemolytic anemia

No event of immune-related hemolytic anemia was report in patients treated with sugemalimab in combination with chemotherapy.

Immune-related hemolytic anemia was reported in 0.2% of patients treated with sugemalimab monotherapy. The event occurred in a single patient, was of Grade 4 in severity. The event was serious, and did not lead to treatment interruption or discontinuation.

Immune-related vasculitis

No event of immune-related vasculitis was report in patients treated with sugemalimab in combination with chemotherapy.

Immune-related vasculitis was reported in 0.2% of patients treated with sugemalimab monotherapy. The event occurred in a single patient, was of Grade 2 in severity. The event was serious and led to treatment discontinuation.

Immune checkpoint inhibitor class effects

There have been cases of the following adverse reaction(s) reported during treatment with other immune checkpoint inhibitors which might also occur during treatment with sugemalimab: pancreatic exocrine insufficiency, coeliac disease.

Infusion-related reactions

Infusion-related adverse reactions were reported in 4.4% of patients treated with sugemalimab in combination with chemotherapy. Reported events were infusion related reaction (0.9%), anaphylactic reaction (0.7%), hyperhidrosis (0.5%), pyrexia (0.5%), erythema, rash, rash maculo-papular, skin depigmentation, skin disorder, skin swelling, chills, oedema peripheral, tenderness, nausea, breath holding and throat irritation (0.2% each), respectively.

Infusion-related adverse reactions were reported in 3.3% of patients treated with sugemalimab monotherapy. Reported events were pyrexia (2.5%), infusion-related reaction (0.4%), and chills, pain, vomiting, dizziness, erythema, and pruritus (0.2% each), respectively.