How effective is the treatment with Ivosidenib?

The approval of ivosidenib for its indicated uses by the U.S. Food and Drug Administration (FDA) was supported by data from the ClarIDHy study. This is the first and only randomized Phase III clinical trial conducted in patients with previously treated isocitrate dehydrogenase 1 (IDH1)-mutated cholangiocarcinoma.

How effective is the treatment with Ivosidenib?

Results from the ClarIDHy study demonstrated that the primary endpoint, progression-free survival (PFS), was significantly improved with statistical significance as assessed by an Independent Review Committee (hazard ratio [HR] = 0.37; 95% confidence interval [95%CI] = [0.25, 0.54]; p < 0.001). The median progression-free survival (95%CI) was 2.7 months (1.6, 4.2) in the ivosidenib (Tibsovo) group versus 1.4 months (1.4, 1.6) in the placebo group. The 6-month and 12-month progression-free survival rates were 32% and 22% in the ivosidenib group, respectively, compared with 0% at both time points in the placebo group.

Precautions Related to Immunization

1. Live attenuated vaccines are prohibited during treatment and for up to 12 months after the end of treatment. The specific duration of contraindication depends on the treatment regimen administered.

2. Consult your physician or pharmacist to confirm the exact duration for which live attenuated vaccines should be avoided.

3. In the UK, live attenuated vaccines include rubella vaccine, mumps vaccine, measles vaccine, bacillus Calmette-Guérin (BCG) vaccine, and yellow fever vaccine.

4. Generally, you may receive the following vaccines, although the protective efficacy of some may be lower than usual:

5. Other types of inactivated vaccines;

6. Influenza vaccine (intramuscular formulation);

7. Coronavirus disease 2019 (COVID-19) vaccine.

8. Discuss with your physician or pharmacist to determine the optimal timing for vaccination that aligns with your cancer treatment cycle.

Precautions for Contact with Vaccinated Individuals

1. You may have normal contact with individuals who have received live attenuated vaccines via injection.

2. If the contact person has received a live attenuated vaccine via oral or nasal spray administration, there is a low risk of vaccine strain transmission if your immune system is weakened.

3. If you need close contact with individuals who have received live attenuated vaccines, your healthcare team will inform you of the necessary protective measures.