Pfizer And GSK To Initiate Study Of Novel Combination Therapy In Patients With Melanoma

Pfizer Inc. announced that it has entered into an agreement with GSK to explore the anti-cancer efficacy and the safety of GSK’s trametinib (GSK1120212) combined with Pfizer’s palbociclib (PD-0332991) in a Phase I/II study (Study 200344) in patients with advanced/metastatic melanoma.

Study 200344 is a dose-escalation, open-label study designed to determine the recommended combination regimen (RCR) for trametinib plus palbociclib in patients with melanoma.  The study will also evaluate the effect of the combination on tumor biomarkers, safety and anti-cancer activity in patients with BRAFV600 wild type melanoma, including those with NRAS mutations.

“Pfizer Oncology is committed to maximizing the value of our portfolio for patients through the study of novel combinations.  This includes combining our own cancer medicines with each other, as well as with those of other companies where there is strong scientific rationale,” said Garry Nicholson, president and general manager, Pfizer Oncology Business Unit.  “Emerging data suggest the potential for trametinib and palbociclib to work together to treat melanoma.  We look forward to collaborating with GSK to explore this potential and evaluate the clinical activity of this combination in melanoma.”

The two companies will collaborate on the study, which GSK will conduct.  Financial terms of the agreement were not disclosed.

Trametinib, a reversible inhibitor of MEK1 and MEK2, is approved by the U.S. Food and Drug Administration (FDA) under the name Mekinist® for the treatment of adult patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutation as detected by an FDA-approved test.  Mekinist is not indicated for the treatment of patients who have received a prior BRAF inhibitor therapy.

Palbociclib is an investigational oral and selective inhibitor of cyclin dependent kinases (CDK) 4 and 6.  In April 2013, palbociclib received Breakthrough Therapy designation by the FDA for the potential treatment of patients with breast cancer. Palbociclib is not approved for any indication in any markets.

Source: Pfizer

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Pfizer: Sutent Potentially Linked to Severe Skin Reactions

Pfizer: Sutent Potentially Linked to Severe Skin Reactions, Such as Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis, Health Canada Says
There have been rare but severe skin reactions in people worldwide taking a medication used to treat cancer of the stomach and bowels, kidney, and pancreas, Health Canada says. Pfizer’s drug, Sutent, is potentially associated with severe and sometimes life-threatening skin rashes such as Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), the regulator said.
Signs and symptoms of the severe skin reactions include:

  •  Initially, reddish target-like spots or circular patches often with central blisters on the trunk or elsewhere on the body.
  •  Rash progressing to widespread blistering or peeling of the skin, blisters in the mouth and ulcers in the eyes.
  • Skin changes may follow fever, tiredness, headache and cough.

Health Canada said early recognition is important in improving prognosis. If signs or symptoms of SJS or TEN occur then treatment with Sutent should be stopped and if the diagnosis of the skin treatments is confirmed then it must not be taken again.
« Out of an estimated 214,848 patients exposed to sunitinib between 26 January, 2006 and 30 April, 2013, there were 4 reported cases of TEN and 5 reported cases of SJS internationally, although diagnosis was not confirmed in all cases, » Health Canada said in a letter to health professionals posted on its website. « Two of the potential TEN cases had fatal outcomes. There have been no Canadian cases reported as of April 30, 2013. »
Pfizer Canada will update the prescribing information for Sutent, sunitinib malate.