Mode of action
What is the general class of inhibitors to which Itovebi belongs?
PI3Ki (phosphoinositide 3-kinase inhibitor)
what is 53 years ?
Median age of patients in the inavolisib group was this many years.
What is primary endpoint of INAVO120?
PFS (Investigators assessed)
What were the 5 most common AEs (any grade) in INAVO 120?
Neutropenia, Stomatitis and mucosal inflammation, Hyperglycemia, Diarrhea, Rash
What is 0.43?
This was the HR for progression free survival in all patients in INAVO120
In addition to PIK3CA mutation, Inavo is also active on patients with AKT1 mutation? True or False
FALSE
How can the PIK3CA mutations be identified?
What is 7.3 and 15 months?
The median progression-free survival for patients treated respectively with Pbo+palbociclib–fulvestrant and inavolisib+palbociclib–fulvestrant
was the dose reduction and modification in the INAVO120 protocol?
Starting dose: 9 mg daily
First dose reduction: 6 mg daily
Second dose reduction: 3 mg daily
Occular toxicities were observed in less than 23% of patients in the Inavo arm, True or False?
TRUE
What is Inavo dual mechanism of action?
high selectivity for p110α protein and facilitation of mutated p110α degradation
What is 319 patients?
The total number of female patients in Inavo120
What was the OS in INAVO120?
The OS data is not mature, but a strong OS trend was observed in INAVO120
What was the Hypergylemia rate in the Itovebi arm in INAVO120?
58.6%
An efficacy benefit was seen with the INAVO120 regimen in both the premenopausal and postmenopausal patients? True or False
TRUE
What is the p110α protein?
Itovebi targets this specific protein encoded by the PIK3CA gene
What CDK4/6i other than Palbociclib can be combined to Inavolisib?
None, the indication is in combination with Palbo
What is 21.3 months?
Median follow-up in the INAVO120 trial.
What is 7 days?
Hyperglycemia median time to onset
What is the next-generation sequencing assay that was primarily used for testing in the INAVO120 trial?
FoundationOne Liquid CDx
Itovebi facilitates the degradation of mutated and wild-type p110α? True or False
FALSE
What is the proportion of patients with a history of Type 1 diabetes or Type 2 diabetes that were included in INAVO120?
0%
what is 58.4%
ORR (Overall Reposne Rate) in the Inavo arm in INAVO120 trial
What is 3.1%?
Permanent discontinuation rate of Itovebi due to any AE
What is the proportion of patients in the Itovebi arm that was treated with anti-hyperglycemic medication?
44%