Adverse reaction profile with AUGTYRO in the TRIDENT-1 study1

The ROS1+ NSCLC safety population included 264 patients from Phase 2 study cohorts who received the recommended dose of AUGTYRO1

8% of patients permanently discontinued AUGTYRO1

Serious adverse reactions occurred in 33% of patients who received AUGTYRO. Serious adverse reactions reported in ≥2% of patients included pneumonia, dyspnea, pleural effusion, and hypoxia. Fatal adverse reactions were reported in 4.2% of patients who received AUGTYRO, including death, pneumonia, pneumonia aspiration, cardiac arrest, sudden cardiac death, cardiac failure, sudden death, hypoxia, dyspnea, respiratory failure, tremor, and disseminated intravascular coagulation.1

Adverse Reaction1*
(≥10%) in patients taking AUGTYRO
All Grades % Grade 3 or 4%
Nervous System Disorders
Dizzinessa 63 1.9
Dysgeusiab 48 0
Peripheral neuropathyc 47 1.9
Ataxiad 28 0.4
Cognitive disorderse 23 0.8
Headachef 19 0
Gastrointestinal Disorders
Constipation 36 0
Nausea 19 0.4
Diarrhea 13 0.4
Vomiting 10 0.8
Respiratory, Thoracic, and Mediastinal Disorders
Dyspneag 30 7
Coughh 14 0
General Disorders
Fatiguei 24 1.1
Edemaj 12 0.8
Musculoskeletal and Connective Tissue Disorders
Muscular weakness 21 1.5
Myalgiak 12 0.4
Metabolism and Nutritional
Increased weight 14 1.9
Eye Disorders
Vision disordersl 11 0
  • Based on NCI CTCAE v4.03.
  • Includes terms dizziness, vertigo, dizziness postural, dizziness exertional, vertigo positional.
  • Includes terms dysgeusia, ageusia, anosmia, hypogeusia.
  • Includes terms neuralgia, neuropathy peripheral, peripheral sensory neuropathy, dysesthesia, peripheral motor neuropathy, polyneuropathy, paresthesia, hypoesthesia, hyperesthesia.
  • Includes terms ataxia, gait disturbance, balance disorder, cerebellar ataxia.
  • Includes terms memory impairment, disturbance in attention, cognitive disorder, confusional state, amnesia, attention deficit hyperactivity disorder, delirium, altered state of consciousness, aphasia, delusion, depressed level of consciousness, hallucination, mental status changes, neurological decompensation.
  • Includes terms headache, migraine, tension headache.
  • Includes terms dyspnea and dyspnea exertional.
  • Includes terms productive cough, cough, and upper-airway cough syndrome.
  • Includes terms fatigue and asthenia.
  • Includes terms generalized edema, periorbital edema, localized edema, face edema, edema peripheral, edema, eye edema, scrotal edema.
  • Includes terms myalgia, myositis, musculoskeletal discomfort, musculoskeletal pain.
  • Includes terms vision blurred, dry eye, visual impairment, visual field defect, cataract, conjunctivitis, eye pain, photophobia, photosensitivity reaction, visual acuity reduced, vitreous floaters, blepharospasm, color blindness, diplopia, eye hematoma, eye swelling, eyelid disorder, eyelid injury, eyelids pruritus, glaucoma, night blindness, ophthalmic herpes zoster.

AUGTYRO is indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).

NSCLC=non-small cell lung cancer; ROS1=proto-oncogene C-Ros1, receptor tyrosine kinase.


1. AUGTYRO [package insert]. Princeton, NJ. Bristol-Myers Squibb Company.