Patients reportedly beating cancer with just one tablet a day

 

An experimental cancer drug appears to have cured every single patient in a small clinical trial conducted in the US.

All 12 patients, who had been diagnosed with rectal cancer, entered into remission after taking dostarlimab for over six months, according to a study published in the New England Journal of Medicine.

Dosage Forms & Strengths

injectable solution

• 50mg/mL (10 mL, single-dose vials)

Mismatch Repair–Deficient (dMMR) Tumors

Indicated for adults with mismatch repair–deficient (dMMR) recurrent or advanced endometrial cancer that has progressed on or following a prior platinum-containing regimen

Also indicated for adults with dMMR recurrent or advanced solid tumours who have progressed on or following previous treatment and have no satisfactory therapeutic options.

Doses 1-4: 500 mg IV q3Weeks, THEN

Dose 5 and thereafter (start 3 weeks after Dose 4): 1,000 mg IV q6Weeks until disease progression or unacceptable toxicity

Dosage Modifications

No dose reductions are recommended

Pneumonitis

• Grade 2: Withhold therapy; resume when complete or partial resolution occurs (Grade <1) after corticosteroid taper
• Permanently discontinue if there is no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone ≤10 mg/day (or equivalent) within 12 weeks of starting steroids.
• Grade 3 or 4 or recurrent Grade 2: Permanently discontinue

Colitis

• Grade 2 or 3: Withhold therapy; resume when complete or partial resolution occurs (Grade <1) after corticosteroid taper
• Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone ≤10 mg/day (or equivalent) within 12 weeks of initiating steroids.
• Grade 4: Permanently discontinue

Hepatitis with no tumor involvement of the liver

• AST or ALT increases to >3 and ≤8x ULN or total bilirubin [TB] increases to >1.5 and <3x ULN: Withhold therapy; resume when complete or partial resolution (Grade <1) occurs after corticosteroid taper
• Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone ≤10 mg/day (or equivalent) within 12 weeks of initiating steroids.
• AST or ALT increases to >8x ULN or TB increases to >3x ULN: Permanently discontinue

Hepatitis with tumour involvement of the liver

• Withhold therapy

  • Baseline AST or ALT >1 and ≤3x ULN and increases to >5 and ≤10x ULN
  • Baseline AST or ALT >3 and ≤5x ULN and increases to >8 and ≤10x ULN
  • Resume when complete or partial resolution occurs (Grade <1) after corticosteroid taper
  • Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone ≤10 mg/day (or equivalent) within 12 weeks of initiating steroids

• Permanently discontinue

  • AST or ALT increases >10x ULN or TB increases to >3x ULN

Endocrinopathies

• Grade 2, 3, or 4: Withhold until clinically stable or permanently discontinue depending on the severity
• Permanently discontinue if no complete or partial resolution (Grade <1) within 12 weeks of initiating steroids or inability to reduce prednisone ≤10 mg/day (or equivalent) within 12 weeks of starting steroids.

Nephritis with renal dysfunction

• Grade 2 or 3 increased blood creatinine: Withhold therapy; resume when complete or partial resolution occurs (Grade <1) after corticosteroid taper
• Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone ≤10 mg/day (or equivalent) within 12 weeks of starting steroids.
• Grade 4 increased blood creatinine: Permanently discontinue

Exfoliative dermatologic conditions

• Suspected Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), or drug rash with eosinophilia and systemic symptoms (DRESS) syndrome: Withhold therapy

• Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone ≤10 mg/day (or equivalent) within 12 weeks of initiating steroids.

• Confirmed SJS, TEN, or DRESS syndrome: Permanently discontinue

Myocarditis

• Grade 2, 3, or 4: Permanently discontinue

Neurologic toxicities

• Grade 2: Withhold therapy; resume when complete or partial resolution occurs (Grade <1) after corticosteroid taper
• Permanently discontinue if there is no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone ≤10 mg/day (or equivalent) within 12 weeks of initiating steroids.
• Grade 3 or 4: Permanently discontinue

Infusion-related reactions

• Grade 1 or 2: Interrupt or slow infusion rate
• Grade 3 or 4: Permanently discontinue

Renal or hepatic impairment

• Mild-severe and end-stage renal disease: No dosage adjustment necessary

Hepatic impairment

• Mild-to-moderate (TB ≤3x ULN and any AST): No dose adjustment is recommended
• Severe: Not studied

Dosing Considerations

Females of reproductive potential: Verify pregnancy status before initiation

Recurrent or advanced dMMR endometrial cancer or solid tumours

• Select patients based on the presence of dMMR in tumour specimens
• Information on FDA-approved tests is available at: http://www.fda.gov/CompanionDiagnostics

“This is the first time this has happened in the history of cancer”, Dr Luis Diaz, one of the lead authors of the paper, told The New York Times.

The patients also experienced no significant side effects during the course of their treatment.

 https://www.independent.co.uk/topic/us -