TEST:

Oncomine™ Dx Target Test

GAVRETO is a kinase inhibitor indicated for treatment of:...Adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer as detected by an FDA approved test (NSCLC).

Adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test

Eli Lilly and Company (NYSE: LLY) today announced the U.S. Food and Drug Administration (FDA) has granted approval to Retevmo® (selpercatinib, 40 mg & 80 mg capsules) for adult patients with locally advanced or metastatic solid tumors with a rearranged during transfection (RET) gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.

ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of:...adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy.

TAFINLAR is indicated, in combination with trametinib, for...the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test.

For patients with advanced NSCLC and an activating HER2 (ERBB2) mutation, as detected by an US Food and Drug Administration–approved test, and who have received prior systemic therapy, clinicians may offer treatment (monotherapy) with trastuzumab deruxtecan...

...EGFR Exon20ins NSCLC population treated at the recommended phase II dose of 1,050 mg amivantamab...The overall response rate was 40% (95% CI, 29 to 51), including three complete responses, with a median duration of response of 11.1 months...Amivantamab, via its novel mechanism of action, yielded robust and durable responses with tolerable safety in patients with EGFR Exon20ins mutations after progression on platinum-based chemotherapy.

The phase II multicenter, open label study, which evaluated efficacy and safety of D+T in pretreated (cohort B) and treatment (tx)-naive (cohort C) pts with BRAF V600E mut metastatic NSCLC....median (m) follow-up was 16.3 mo in tx-naïve pts and 16.6 mo in pretreated pts.mOS was 17.3 mo (95% CI: 12.3, 40.2; 3 yr OS: 40%) and 18.2 mo (95% CI: 14.3, 28.6; 3 yr OS: 33%) with 14/36 and 11/57 pts alive in tx naïve and pretreated pts respectively....This update of BRF113928 study reported improved and durable OS rates with combination D+T in BRAF V600E mut NSCLC pts.

This study reports the case of a 57-year-old male diagnosed as having stage IIIC squamous cell lung cancer. Oncomine Dx Target Test identified EGFR exon19 deletion and de novo EGFR T790M mutation with variant allele frequencies (VAF) of 21.6% and 25.2%, respectively. The patient was treated with osimertinib after progression on chemoradiotherapy followed by durvalumab, and a partial response was maintained for more than 20 months.

The patient was diagnosed with lung adenocarcinoma...A genetic analysis of the primary tumor using the Oncomine Dx target test multi-CDx system revealed positivity for EGFR (L858R and E709X) and CTNNB1 mutations….The patient was treated with afatinib as first-line therapy and achieved clinical improvement and a partial response and is continuing treatment 1 year later.

A 67-year-old Japanese male never-smoker was diagnosed with stage IA3 lung adenocarcinoma….An Oncomine Dx target test of the resected specimen was positive for the BRAF V600E mutation. He was started on dabrafenib 150 mg twice per day and trametinib 2 mg once per day. He had a good clinical response to dabrafenib/trametinib therapy with resolution of abdominal distention. He continued dabrafenib/trametinib treatment without disease progression for 7 months, with no severe adverse effects.

...we present a case report of a patient with GBC harboring ERBB2 activating mutation on both the primary site and metachronous liver metastasis...we performed genomic profiling from the liver tumor using the NGS panel, Oncomine® Target Test system (OTT, Thermo Fisher Scientific). This revealed ERBB2 Ser310Phe (c.929C>T; VAF, 26%)...we treated the patient with lapatinib with a combination of capecitabine....Within a week of treatment, she experienced major subjective clinical improvement, which included resolution of peripheral edema. After 2 cycles of treatment, contrasted CT imaging showed a decrease in the size of tumor emboli and hepatic lesion...