February 22, 2024

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Roche’s inavolisib Phase III study yields positive results

Roche’s inavolisib Phase III study yields positive results



Roche’s inavolisib Phase III study yields positive results

Roche recently announced positive results from the Phase III clinical trial, INAVO120, for inavolisib. The study demonstrated a significant extension of progression-free survival (PFS) in first-line treatment when inavolisib was combined with palbociclib and fulvestrant.

Inavolisib, in combination with palbociclib and fulvestrant, emerged as a promising first-line treatment option for locally advanced or metastatic breast cancer patients with HR-positive, HER2-negative, and endocrine-resistant mutations in the PIK3CA gene.

 

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The study met its primary endpoint of prolonged PFS, showing statistically and clinically significant improvements compared to the monotherapy with palbociclib and fulvestrant. While overall survival (OS) data are still maturing, there is a clear positive trend observed, with further analysis planned.

The combination treatment with inavolisib demonstrated good tolerability, with adverse reactions consistent with known safety profiles and no new safety signals observed.

Inavolisib, an oral medication, exhibits high selectivity in inhibiting PI3Κα and specifically degrading PI3Κα mutant proteins. With its unique dual-action mechanism, inavolisib offers good tolerability, sustained disease control, and a potential improvement in prognosis for patients with HR-positive/HER2-negative advanced breast cancer harboring PIK3CA mutations. These mutations can lead to alterations in the PI3Κα protein, causing uncontrolled tumor growth, disease progression, and resistance to endocrine therapy.

Currently, inavolisib is undergoing three Phase III clinical trials (INAVO120, INAVO121, INAVO122) with different combination regimens in metastatic breast cancer patients with PIK3CA mutations.

 

About the INAVO120 Study

The INAVO120 study [NCT04191499] is a Phase III, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of inavolisib in combination with palbociclib and fulvestrant compared to placebo with palbociclib and fulvestrant in locally advanced or metastatic breast cancer patients with PIK3CA mutations, hormone receptor-positive, and HER2-negative. Patients who experienced disease progression during or within 12 months after completion of adjuvant endocrine therapy and had not received prior systemic treatment for metastatic disease were eligible for inclusion.

The study included 325 patients who were randomly assigned to either the treatment or control group. The primary endpoint was investigator-assessed progression-free survival, defined as the time from randomization to disease progression or death from any cause. Secondary endpoints included overall survival, objective response rate, and clinical benefit rate.

 

About Inavolisib

Inavolisib is an innovative oral targeted therapy that provides good tolerability, sustained disease control, and a potential improvement in prognosis for breast cancer patients with HR-positive and PIK3CA mutations. With a mutation rate of approximately 40%, PIK3CA mutations are common but often overlooked in breast cancer patients. Inavolisib is designed to reduce overall treatment toxicity, differing from other PI3K inhibitors with its high potency and specificity in inhibiting PI3Kα in vitro, along with a unique mechanism to degrade PI3Kα mutant forms.

Inavolisib is currently being investigated in three Phase III clinical trials for locally advanced or metastatic breast cancer with PIK3CA mutations:

  • Combination of palbociclib and fulvestrant vs. palbociclib and fulvestrant monotherapy in first-line treatment for HR-positive/HER2-negative breast cancer (INAVO120).
  • Combination of fulvestrant vs. alpelisib in combination with fulvestrant for the treatment of CDK4/6 inhibitor-resistant HR-positive/HER2-negative breast cancer (INAVO121).
  • Combination of pertuzumab-trastuzumab subcutaneous injection (Phesgo®) vs. Phesgo as first-line maintenance treatment for HER2-positive breast cancer (INAVO122).

Roche’s inavolisib Phase III study yields positive results


(source:internet, reference only)

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