https://www.msd-australia.com.au/news/cancer-therapies-receive-re...

https://www.msd-australia.com.au/news/cancer-therapies-receive-recommendations-from-the-pharmaceutical-benefits-advisory-committee/

27/4/2021

KEYTRUDA SELECTED SAFETY INFORMATION2 Precautions: Immune-mediated adverse reactions (ImARs), incl. severe and fatal cases, have occurred in patients receiving KEYTRUDA. These have included, but not limited to: pneumonitis, colitis, hepatitis, hepatoxicity (in combination with axitinib), nephritis, endocrinopathies (adrenal insufficiency, hypophysitis, type 1 diabetes mellitus, hyperthyroidism, hypothyroidism, thyroiditis), severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis and bullous pemphigoid), uveitis, myositis, Guillain-Barre syndrome, pancreatitis, encephalitis, sarcoidosis, myasthenic syndrome/myasthenia gravis (incl. exacerbation), myelitis, vasculitis, myocarditis, pericarditis and pericardial effusion, peripheral neuropathy, sclerosing cholangitis, solid organ transplant rejection, severe infusion reactions (hypersensitivity, anaphylaxis) and complications of allogeneic HSCT. ImARs have occurred after discontinuation of treatment with KEYTRUDA. ImARs can affect more than one body system simultaneously. Thyroid and liver function tests should be performed at baseline, periodically during treatment and as indicated based on clinical evaluation. Withhold or discontinue KEYTRUDA to manage adverse reactions as described in the Product Information. Adverse events: In patients with endometrial carcinoma treated with KEYTRUDA/LENVIMA, the following adverse events occurred at a rate >20% and at a rate higher than doxorubicin or paclitaxel were: hypothyroidism (67% vs 0.9%), hypertension (67% vs 6%), haemorrhagic events (25% vs 15%), fatigue (58% vs 54%), diarrhoea (55% vs 20%), nausea (49% vs 47%), vomiting (37% vs 21%), stomatitis (35% vs 26%), abdominal pain (34% vs 21%), constipation (27% vs 25%), musculoskeletal disorders (53% vs 27%), decreased appetite (44% vs 21%), weight loss (34% vs 6%), proteinuria (29% vs 3.4%), urinary tract infection (31% vs 13%) , headache (26% vs 9%), dysphonia (22% vs 0.6%), palmar-plantar erythrodysesthesia (23% vs 0.9%) and rash (20% vs 4.9%). Fatal adverse events have occurred. In patients with head and neck cancer, KEYTRUDA was discontinued for adverse reactions in 12% of patients in the KEYTRUDA single agent arm. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were sepsis (1.7%) and pneumonia (1.3%). Adverse reactions leading to the interruption of KEYTRUDA occurred in 31% of patients; the most common adverse reactions leading to interruption of KEYTRUDA (≥2%) were pneumonia (2.3%), pneumonitis (2.3%), and hyponatremia (2%). KEYTRUDA was discontinued for adverse reactions in 16% of patients in the combination arm. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonia (2.5%), pneumonitis (1.8%), and septic shock (1.4%). Adverse reactions leading to the interruption of KEYTRUDA occurred in 45% of patients; the most common adverse reactions leading to interruption of KEYTRUDA (≥2%) were neutropenia (14%), thrombocytopenia (10%), anaemia (6%), pneumonia (4.7%), and febrile neutropenia (2.9%). Contraindications: None.Refer to the Consumer Medical Information leaflet, available online or your doctor or pharmacist for further information about KEYTRUDA.

I'm guessing that this has something to do with it, an article from MSD website last week, Imugene probably has cold feet.