What is the mechanism of action of this treatment?

Common treatments for lung cancer, such as immunotherapies and targeted therapies, work by enhancing the body's immune response against cancer cells or by directly targeting specific molecules involved in cancer growth. Immunotherapies like pembrolizumab and nivolumab inhibit PD-1/PD-L1 interactions, preventing cancer cells from evading immune detection. Bintrafusp alfa, a bifunctional fusion protein, targets both TGF-β and PD-L1 pathways, aiming to reduce immunosuppression and enhance anti-tumor immunity. These mechanisms are crucial for lung cancer patients as they offer more personalized and effective treatment options, potentially improving survival rates and quality of life.

What side effects are associated with this type of intervention?

Common treatments for lung cancer, particularly those involving immune checkpoint inhibitors like pembrolizumab, atezolizumab, and combination therapies, often result in side effects such as neutropenia, febrile neutropenia, hypertension, rash, stomatitis, and pneumonitis. These treatments can also lead to immune-related adverse events, including diarrhea, pruritus, and pneumonitis. The severity of these side effects can range from mild to severe, with some cases requiring discontinuation of treatment.

What prior FDA approvals exist?

Several drugs targeting the PD-1 and PD-L1 pathways have received FDA approval for the treatment of lung cancer. Pembrolizumab, an anti-PD-1 antibody, is approved for use in combination with chemotherapy or as monotherapy in patients with PD-L1-positive tumors. Nivolumab, another anti-PD-1 antibody, is approved for previously treated advanced NSCLC. Atezolizumab, an anti-PD-L1 antibody, is approved in combination with chemotherapy for first-line treatment of metastatic nonsquamous NSCLC. Durvalumab, also targeting PD-L1, is approved for patients with unresectable stage III NSCLC following chemoradiation. These treatments share similarities with Bintrafusp Alfa, which targets both TGF-β and PD-L1 pathways.

What other types of research exist?

Promising novel alternatives to Bintrafusp Alfa for lung cancer patients include Cemiplimab and the combination of Tremelimumab and Durvalumab. Cemiplimab, in combination with platinum-based chemotherapy, has shown improved survival rates in NSCLC patients. Similarly, the combination of Tremelimumab and Durvalumab with chemotherapy has demonstrated better outcomes in terms of overall survival and progression-free survival in patients with metastatic NSCLC.

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Bintrafusp Alfa Continuation for Cancer

Phase 3

Waitlist Available

Research Sponsored by EMD Serono Research & Development Institute, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants currently on active bintrafusp alfa treatment alone or following discontinuation of other combination treatment agents in the parent study without treatment interruption

Participants who experienced a confirmed complete response (CR), partial response (PR), or stable disease (SD) in an eligible parent study and subsequently developed disease progression

Must not have

Participants reinitiating treatment with bintrafusp alfa at study entry after receiving systemic anticancer therapies/treatments

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial offers bintrafusp alfa to patients. The medication helps the immune system fight cancer by blocking proteins that stop it from attacking cancer cells.

Who is the study for?

This trial is for patients already receiving bintrafusp alfa in other studies, without treatment interruption. It's open to those who've had stable disease or controlled side effects after stopping the drug, and are not pregnant nor have severe allergies to its ingredients. Participants must agree to use effective contraception.

What is being tested?

The study provides ongoing access to bintrafusp alfa for lung cancer patients from previous trials and collects long-term data on its safety and effectiveness. Treatment continues until set criteria are met, it becomes commercially available, or the study ends.

What are the potential side effects?

While specific side effects aren't listed here, participants with well-controlled or resolved adverse events from prior bintrafusp alfa use can join. Those with permanent discontinuation due to certain immune-related issues or bleeding events cannot participate.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am currently being treated with bintrafusp alfa, without any breaks.

Select...

My cancer initially responded to treatment but has now worsened.

Select...

My cancer is stable and I have no other treatment options.

Select...

I stopped taking bintrafusp alfa due to side effects, which are now under control or gone.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am restarting bintrafusp alfa treatment after other cancer treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2022 Phase 2 trial • 146 Patients • NCT04246489

55%

Anaemia

21%

Nausea

18%

Haematuria

17%

Pyrexia

16%

Asthenia

16%

Decreased appetite

16%

Rash

15%

Constipation

14%

Vomiting

14%

Alanine aminotransferase increased

13%

Aspartate aminotransferase increased

12%

Hypothyroidism

12%

Gingival bleeding

12%

Pruritus

10%

Urinary tract infection

10%

Hypoalbuminaemia

10%

Fatigue

Cough

Disease progression

Abdominal pain

Diarrhoea

Oedema peripheral

Hypokalaemia

Headache

Insomnia

Vaginal haemorrhage

Hyperthyroidism

Stomatitis

Blood alkaline phosphatase increased

Lipase increased

Back pain

Blood creatinine increased

Weight decreased

Hyponatraemia

Arthralgia

Amylase increased

Colitis

General physical health deterioration

Pulmonary embolism

Hydronephrosis

Acute kidney injury

Cancer pain

Malignant ascites

Urinary bladder haemorrhage

Pathological fracture

Urinary retention

Malignant pleural effusion

Bladder cancer

Myositis

Blood loss anaemia

Adrenal insufficiency

Immune-mediated thyroiditis

Inappropriate antidiuretic hormone secretion

Secondary adrenocortical insufficiency

Anal haemorrhage

Dental caries

Gastric haemorrhage

Gastric ulcer haemorrhage

Ileus

Malignant gastrointestinal obstruction

Mouth ulceration

Obstructive defaecation

Pancreatitis

Malaise

Pain

Cholangitis acute

Drug-induced liver injury

Hepatic function abnormal

Hepatic pain

Abdominal sepsis

Brain abscess

Intestinal fistula infection

Pyelonephritis

Pyelonephritis acute

Sepsis

Septic arthritis streptococcal

Urinary tract infection bacterial

Urosepsis

Cystitis radiation

Lumbar vertebral fracture

Radiation proctitis

Spinal compression fracture

Diabetic ketoacidosis

Malnutrition

Type 1 diabetes mellitus

Metastases to spine

Squamous cell carcinoma of skin

Tumour haemorrhage

Tumour pain

Altered state of consciousness

Brain oedema

Embolic stroke

Myasthenia gravis

Renal failure

Ureteral polyp

Female genital tract fistula

Genital haemorrhage

Intermenstrual bleeding

Asphyxia

Dyspnoea

Pulmonary thrombosis

Erythema multiforme

Immune-mediated dermatitis

Deep vein thrombosis

Haematoma

Hypovolaemic shock

Venous thrombosis limb

Febrile neutropenia

Cardiac failure

Pancreatitis acute

Rectal haemorrhage

Subileus

Kidney infection

Lung abscess

Stoma obstruction

Transaminases increased

Neuritis

Polyneuropathy in malignant disease

Device dislocation

Cystitis haemorrhagic

Haemorrhage urinary tract

100%

80%

60%

40%

20%

Study treatment Arm

Bintrafusp Alfa

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Bintrafusp alfaExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bintrafusp alfa

2020

Completed Phase 2

~1150

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for lung cancer, such as immunotherapies and targeted therapies, work by enhancing the body's immune response against cancer cells or by directly targeting specific molecules involved in cancer growth. Immunotherapies like pembrolizumab and nivolumab inhibit PD-1/PD-L1 interactions, preventing cancer cells from evading immune detection. Bintrafusp alfa, a bifunctional fusion protein, targets both TGF-β and PD-L1 pathways, aiming to reduce immunosuppression and enhance anti-tumor immunity. These mechanisms are crucial for lung cancer patients as they offer more personalized and effective treatment options, potentially improving survival rates and quality of life.

[30- and 90-day Lethality in Patients with Stage IV Lung Cancer Depending on the Primary Therapy].