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Targeted Tx Stalls Melanoma Progress

New drug attacks mutations — but not without side effects.

By Crystal Phend, MedPage Today

Medically Reviewed by Robert Jasmer, MD

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CHICAGO — MONDAY, June 4, 2012 (MedPage Today) —A novel drug targeted at the BRAF mutations common in metastatic melanoma appears to substantially slow progression, a clinical trial showed.

Dabrafenib boosted progression-free survival (PFS) by 70 percent in patients with BRAF-mutated tumors compared with standard chemotherapy alone, Axel Hauschild, MD, of Universitaetsklinikum Schleswig-Holstein in Kiel, Germany, and colleagues found.

The median time to progression or death reached 5.1 months compared with 2.7 on dacarbazine (DTIC-Dome) chemotherapy, the group reported here at the American Society of Clinical Oncology (ASCO) meeting.

"For BRAF-mutated patients, standard of care is no longer DTIC. Each and every patient needs to be offered a BRAF inhibitor," Hauschild said at an ASCO. "It's the beginning of a completely new era in treatment of metastatic melanoma."

Dabrafenib selectively blocks BRAF similar to vemurafenib (Zelboraf), which was approved for metastatic and unresectable melanoma last fall.

Both oral agents target the V600E mutation that accounts for most of the roughly half of advanced melanomas with a BRAF mutation.

The BREAK-3 trial included 250 patients with stage III, V600E-mutated metastatic melanoma randomized to 150 mg of dabrafenib twice daily or 1,000 mg of IV dacarbazine chemotherapy every 3 weeks, with the option to cross over at signs of disease progression.

Most patients had disease control on dabrafenib. Best confirmed response rates with the drug and with chemotherapy, respectively were:

  • Complete response in 3 percent versus 0 percent
  • Partial response in 50 percent versus 19 percent
  • Stable disease in 40 percent versus 30 percent

With just 12 percent of patients having died, the overall survival results were too immature to present, according to Hauschild.

Treatment-related adverse events were nearly all grade 3 or less. The most common adverse events were hyperkeratosis in 51 percent, palmar-plantar hyperkeratosis in 21 percent, arthralgia (16 percent), and fatigue and headache (both 17 percent).

Treatment discontinuation due to adverse events was uncommon at 3 percent in both groups.

Drugmaker GlaxoSmithKline announced plans to apply for FDA approval of both dabrafenib and trametinib as single agents for treatment of metastatic melanoma.

"The next step is the combination of BRAF and MEK inhibition with dabrafenib and trametinib, not only for stage IV but also in the adjuvant setting," Hauschild said.

Another trial reported at the meeting showed high disease response rates with that combination. Others are ongoing.

The results from the BREAK-3 trial confirms that BRAF targeting is effective, but may give dabrafenib the edge with regard to safety, noted ASCO press conference moderator Sylvia Adams, MD, of New York University Langone Medical Center in New York City.

The novel drug showed a lower risk of the serious skin events seen with vemurafenib. Dabrafenib was associated with a 7 percent risk of squamous cell carcinoma or keratoacanthoma and a 3 percent rate of photosensitivity in the trial.

After 50 years without any good treatments, the recent blossoming in metastatic melanoma options in the clinic, and on the horizon, may mean some work in sorting out treatment algorithms, acknowledged Caroline Robert, MD, PhD, of Institut Gustave Roussy in Villejuif, France.

"It's not a problem, it's good news," Roberts told reporters at the press conference, where she presented similarly good results with another novel drug in the related MEK pathway, trametinib.

What it also means is that mutation testing is becoming increasingly important in melanoma, Hauschild noted.

An upcoming update of German guidelines makes BRAF testing mandatory, he toldMedPage Today.






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Date: 14.12.2018, 16:07 / Views: 75381