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Two new studies show that patients with advanced HR-positive, HER2-negative breast cancer had higher survival when they received combination therapies.
A new study found that FOXA1 missense mutations were enriched in metastatic breast tumors and were associated with lower response to aromatase inhibitors.
The drugmaker said it is working with centers of excellence in Canada to set up companion diagnostic testing to identify patients with PIK3CA mutations.
The commission took the earlier CHMP recommendation to approve the treatment based on the positive results from the Phase III SOLAR-1 trial.
The Phase Ib/II trial will assess dosage and antitumor activity of MEN1611 plus Erbitux for patients with PIK3CA-mutated, RAS and RAF wildtype advanced colorectal cancer.
The agency made its decision based on the SOLAR-1 study showing a five-month progression-free survival benefit for Piqray plus fulvestrant over just fulvestrant.
In ASCO studies, one PI3K inhibitor showed efficacy in PIK3CA-mutated breast cancer patients progressing on CDK4/6 inhibitors, while the other yielded less encouraging signals.
However, the translational biomarker analysis suggested that high HER2 expression after neoadjuvant treatment may signal resistance to adjuvant Herceptin.
A study of both tissue and blood samples from patients in a small trial found that liquid biopsy may detect putative resistance mutations missed in tissue.
A study evaluated data from a Phase I/II trial of Piqray combined with an aromatase inhibitor to find mechanisms of resistance hindering clinical benefit from the therapy.