http://www.pressexaminer.com/braf-v600-is-targetable-in-some-nonmelanoma-cancers/45887
“Efforts by the Cancer Genome Atlas and other initiatives to
characterize the genetic landscape of most tumor types have identified BRAF V600
mutations in nonmelanoma cancers, including colorectal cancer, NSCLC,
papillary thyroid cancer, diffuse gliomas, cholangiocarcinoma,
hairy-cell leukemia, multiple myeloma, Langerhans’-cell histiocytosis
and Erdheim-Chester disease”.
In the cancer types with less response, Hyman noted, the BRAF V600
mutation is typically present in fewer than 5 percent of tumors that
have resisted conventional therapy and spread, so only those patients
would be candidates for the drug.
But the so-called “basket” study from South San Francisco-based
Genentech (NYSE: DNA) and its Swiss parent, Roche (SWX: RO), is
significant because it is the first completed clinical trial lumping
together several genetically similar cancers. Conducted by researchers
at the Memorial Sloan Kettering Cancer Center, phase 2 results from a
basket trial evaluated the effect of vemurafenib on nonmelanoma BRaf
V600-mutated cancers in 122 patients across 23 global centers.
One patient in the study, MaryAnn Anselmo, had been diagnosed with stage 4 glioblastoma in 2013.
Patients with colorectal cancer received oral vemurafenib (960 mg
twice daily) alone (n = 10) or with IV cetuximab (Erbitux; Bristol-Myers
Squibb, Lilly) at a loading dose of 400 mg/m, followed by a weekly
250-mg/m dose (n = 27). That gene makes a protein that directs cell
growth but is mutated in certain cancer patients. “Not only did 40
percent meet strict criteria for response, but almost all of them had
improvement in their symptoms and no one progressed while receiving the
medicine”, said Dr. Hyman. Secondary endpoints included PFS, OS,
duration of response and safety. According to the data, the
non-small-cell lung cancer cohort had a response rate of 42%, with a
median progression-free survival time of 7.3 months.
The goal was to see if the drug vemurafenib, already approved for metastatic melanoma cases with the BRAF mutation, would work in other tumors with the same mutation.
Forty-three percent (95% CI, 18-71) of patients with ECD or LCH
achieved a response. Patients were enrolled in six prespecified cancer
cohorts, and patients with all other tumor types were enrolled in the
seventh cohort.
In the new study, researchers focused on a mutation known as BRAF V600,
which is a defect in a genetic instruction that tells a cell when to
die. “We have proven that histology-independent, biomarker-selected
basket studies are feasible and can serve as a tool for developing
molecularly targeted cancer therapy”, said Dr. Baselga, the study’s
senior author. “Confirmation of promising activity identified in basket
studies will often necessitate additional studies”.
The study was funded by F. Hoffmann-La Roche/Genentech.
Overall Hyeman stays optimistic about the study’s findings.
I was diagnosed with thyroid cancer in Nov., 1999. Surgery and radioactive iodine followed. In Dec., 2006, I found a lump in my neck that turned cancerous. Shortly thereafter, it was found to have metastasized throughout my body and to be untreatable and inoperable. I started a clinical trial with Sutent (sunitinib) since Apr., 2007. In Nov., 2013, the tumors began growing again and I was removed from the Sutent Clinical Trial. I started a clinical trial taking of CEDIRANIB on 04/09/14.
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