Capivasertib is a groundbreaking oral cancer drug advanced with the aid of AstraZeneca, designed to target and inhibit AKT – a key protein concerned in most cancers cell boom and survival. Also recognized with the aid of using its developmental code AZD5363, Capivasertib has won international interest for its promising effects in treating numerous cancers, especially hormone receptor-positive (HR+), HER2-terrible superior breast most cancers, and different AKT-established tumors.
As studies into the center of most cancer treatment options intensifies, Capivasertib has emerged as a first-rate participant in the precision oncology arena. Approved with the aid of using the U.S. FDA in November 2023 under the emblem called Trap, Capivasertib is now part of preferred care in precise breast cancer instances, specially while blended with hormone remedy like fulvestrant.
Why is Capivasertib Important in Cancer Treatment?
Capivasertib belongs to a category of medicine known as AKT inhibitors. The AKT pathway (PI3K/AKT/mTOR pathway) is important in regulating most cancers cell survival, proliferation, and resistance to remedy. In many cancers, this pathway is overactive because of mutations in genes like PIK3CA, AKT1, or PTEN.
Key Significance:
Targets a Specific Cancer Pathway: Capivasertib blocks AKT, thereby interfering with most cancers cells’ cap potential to survive.
Overcomes Resistance: It is especially beneficial in instances wherein resistance to hormone remedy develops.
Precision Medicine Approach: Works quality in cancers with precise genetic mutations, making it an crucial device in personalised most cancers remedy.
Mechanism of Action: How Does Capivasertib Work?
Capivasertib works with the aid of selectively inhibiting all 3 isoforms of AKT (AKT1, AKT2, and AKT3). AKT is a part of a sign transduction pathway that, while activated, promotes cell boom and forestalls apoptosis (programmed cell death). In many types of cancer, this pathway is continuously lively because of mutations.
By inhibiting AKT:
Capivasertib halts the signaling that lets most cancer cells grow.
It restores the cap potential of cells to go through apoptosis.
It can decorate the efficacy of current treatment options, specially endocrine treatment options like fulvestrant in breast cancer.
Current Approved Use of Capivasertib (Truqap)
As of early 2025, the number one approval of Capivasertib under the emblem call Trap is for:
HR+/HER2- superior breast most cancers
In aggregate with fulvestrant
In sufferers with PIK3CA/AKT1/PTEN-altered tumors, following development on endocrine remedy
This approval changed into primarily based totally at the effects of the CAPItello-291 Phase III trial, which confirmed a statistically big development in development-unfastened survival (PFS) for sufferers on Capivasertib plus fulvestrant as opposed to placebo plus fulvestrant.
Clinical Trial Data: What Do the Studies Say?
CAPItello-291 Trial (Phase III):
Population: 708 sufferers with HR+/HER2- breast most cancers
Result:
Median PFS: 7.2 months with Capivasertib vs. three.6 months with placebo
Benefit discovered especially in tumors with PIK3CA/AKT1/PTEN alterations
Objective Response Rate (ORR): Significantly better in Capivasertib arm
Safety Profile: Manageable and constant with recognized facet consequences of AKT inhibitors
Other Ongoing Trials:
CAPItello-280 (Prostate most cancers)
CAPItello-292 (Head and neck most cancers)
Combinations with immunotherapy and chemotherapy
Investigational research in triple-terrible breast most cancers (TNBC) and gynecological cancers
Side Effects of Capivasertib
Like many centered treatment options, Capivasertib has a wonderful facet impact profile that sufferers and healthcare companies need to be conscious of.
Common Side Effects:
Diarrhea
Fatigue
Rash
Nausea
Decreased appetite
Hyperglycemia (accelerated blood sugar)
Serious however Rare:
Severe infections
Hepatotoxicity
Severe pores and skin reactions
Vision problems (rare)
Note: Side consequences are normally conceivable with dose changes and supportive care.
How is Capivasertib Taken?
Capivasertib is taken orally, generally in intermittent dosing schedules to decorate tolerability:
4 days on, 3 days off (e.g., Monday to Thursday)
Taken in aggregate with different pills like fulvestrant (injected)
Your oncologist will decide the precise dosing time table primarily based totally on man or woman most cancers type, genetic profile, and response.
Who is Capivasertib For?
Ideal Candidates:
Patients with HR+/HER2- superior breast most cancers
Those with precise genetic mutations in the PI3K/AKT/PTEN pathway
Individuals who’ve improved on earlier endocrine remedy
Not Recommended For:
Patients with lively extreme infections
Those not able to manipulate hyperglycemia or different metabolic facet consequences
Individuals now no longer displaying the genetic mutations centered with the aid of using Capivasertib (until in a medical trial)
Capivasertib vs. Other Targeted Therapies
Capivasertib (Triqap)
Target: Inhibits all 3 AKT isoforms (AKT1, AKT2, AKT3)
Main Use: HR+/HER2- superior breast most cancers with PIK3CA, AKT1, or PTEN mutations
Mechanism: Blocks a key protein in the PI3K/AKT/mTOR pathway to lessen tumor cell survival and resistance
Side Effects: Diarrhea, fatigue, rash, nausea, hyperglycemia
Form: Oral tablet, taken on an intermittent time table (4 days on, three days off)
Genetic Testing Required: Yes – for PIK3CA, AKT1, or PTEN mutations
FDA Status: Approved in 2023 (U.S.) in aggregate with fulvestrant
Best For: Patients with AKT1/PTEN-altered tumors or the ones proof against endocrine remedy
Alpelisib (Piqray)
Target: Selectively inhibits the PI3K-alpha isoform
Main Use: HR+/HER2- superior breast most cancers with PIK3CA mutations best
Mechanism: Blocks PI3K signaling to lessen tumor boom
Side Effects: Severe rash, hyperglycemia, diarrhea, nausea
Form: Oral, taken daily
Genetic Testing Required: Yes – mainly for PIK3CA mutation
FDA Status: Approved in 2019 (U.S.) with fulvestrant
Best For: Patients with showed PIK3CA mutations
Everolimus (Afinitor)
Target: Inhibits mTOR, downstream of AKT in the equal pathway
Main Use: HR+/HER2- breast most cancers, kidney most cancers, pancreatic neuroendocrine tumors
Mechanism: Prevents most cancers cell boom with the aid of using disrupting mTOR-pushed protein synthesis
Side Effects: Mouth ulcers (stomatitis), infections, fatigue, pneumonitis
Form: Oral, taken daily
Genetic Testing Required: No – used extra extensively with no need mutation profiling
FDA Status: Approved for a couple of cancers due to the fact that 2009
Best For: Broader use, specially while genetic trying out is unavailable or inconclusive
Cost and Availability
FDA-Approved Name: Triqap
Manufacturer: AstraZeneca
Cost: Estimated between $10,000 to $15,000/month relying on healthcare device and insurance
Available: Currently in the U.S., with pending approvals in the EU, UK, and different regions
Final Thoughts
Capivasertib is a progressive step in most cancers, especially for sufferers with confined alternatives because of resistance to traditional treatment options. By focusing on the AKT pathway, it now no longer presents a tailor-made remedy method however additionally opens doorways to destiny precision oncology.
FAQs
How long can you take Capivasertib?
Patients can take Capivasertib so long as most cancers are responding and facet consequences stay conceivable. Treatment length varies with the aid of using man or woman.
What cancers does Capivasertib treat?
As of now, its main indication is HR+/HER2- breast cancer, but trials are underway for prostate, ovarian, TNBC, and head & neck cancers.
Can Capivasertib cure cancer?
Capivasertib is not a cure but a disease-controlling agent, prolonging survival and quality of life when cancer has become resistant to previous treatments.
Can I get Capivasertib in the UK or India?
Regulatory approvals outside the U.S. are in progress. Patients may access it via clinical trials or compassionate use programs.
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