>>NEW ORLEANS, June 5 (Reuters) - An experimental drug being developed by Amgen Inc (NasdaqNM:AMGN - News). and Abgenix (NasdaqNM:ABGX - News) reduced tumors in about 10 percent of colon cancer patients who previously failed to benefit from chemotherapy, researchers said on Saturday.
Researchers said that was comparable to typical reductions seen among patients who have taken an older but similar treatment called Erbitux sold by ImClone Systems Inc (NasdaqNM:IMCL - News). and Bristol-Myers Squibb Co.
The mid-stage, or Phase II, trial involved 148 patients with colon cancer that had spread to other parts of the body. They had all previously been treated with the standard treatment 5FU and either of two other chemotherapy agents, Pfizer's (NYSE:PFE - News).'Camptosar (irinotecan) or Sanofi-Synthelabo's Eloxatine (oxaliplatin).
About 10 percent of the patients who took the Amgen/Abgenix medicine, called panitumumab, saw their tumors shrink by 50 percent or more.
Like Erbitux, the drug is a monoclonal antibody that works by blocking a protein called epidermal growth factor that helps tumors grow. But it is fully human, whereas Erbitux contains fragments of mouse proteins.
Panitumumab was shown to be "well-tolerated" with a reversible skin rash as the most common side effect. Some patients also experienced fatigue, nausea and mild diarrhea, the researchers said.
Dr. Randolph Hecht said Erbitux has caused allergic reactions in some patients that the Amgen drug might avoid, because of its fully human nature. But he said the theoretical safety advantage has not yet been demonstrated, and would need to be seen in a large late-stage trial to be proven.
The drug is also under study as a treatment for lung and kidney cancers, the company said.<<
>>ABX-EGF in combination with paclitaxel and carboplatin for advanced non-small cell lung cancer (NSCLC).
Abstract No: 7083
Author(s): J. Crawford, A. B. Sandler, L. A. Hammond, J. Schiller, C. Belani, M. Kozloff, D. Johnson, A. Fleishman, S. Lee, K. Takeshita; Duke University Medical Center, Durham, NC; Vanderbilt-Ingram Cancer Center, Nashville, TN; Cancer Therapy and Research Center, San Antonio, TX; University of Wisconsin, Madison, WI; University of Pittsburgh Cancer Institute, Pittsburgh, PA; Ingalls Hospital, Harvey, IL; Amgen Inc., Thousand Oaks, CA
Abstract: Background: ABX-EGF is a high-affinity, fully human, IgG2 monoclonal antibody directed against epidermal growth factor receptor (EGFr). This is a report of results from part 1 of a 2-part, phase 2 trial to evaluate the efficacy, safety, and pharmacokinetics (PK) of ABX-EGF in combination with paclitaxel and carboplatin for advanced NSCLC. Methods: In this open-label, sequential, dose-escalation design in pts with NSCLC (stage IIIb or IV) and EGFr expression of 2+ or 3+ in >=10% of tumor cells, pts received weekly IV ABX-EGF in combination with standard paclitaxel and carboplatin every 3 weeks for up to 6 cycles; pts with response or stable disease could receive extended ABX-EGF therapy. Responses (RECIST) were evaluated at week 6 with confirmation >=3 weeks later. The PK of ABX-EGF and paclitaxel were evaluated at weeks 0 and 3. Results: Nineteen pts (5 men/14 women; mean [SD] age 52.2 [11.9] years) were enrolled into 3 ABX-EGF cohorts: 1.0 mg/kg (n=6), 2.0 mg/kg (n=7), and 2.5 mg/kg (n=6). One pt (5%) had a confirmed complete response (1.0 mg/kg) and 4 pts (21%) had partial responses (2 at 2.0 mg/kg and 2 at 2.5 mg/kg) by investigator assessment. The most common adverse event (AE) was skin rash (89% overall; 83%, 100%, and 83% in the 1.0, 2.0, and 2.5 mg/kg groups). The incidence of grade 3 skin rash did not appear to increase with dose (17% at 1.0 mg/kg, 29% at 2.0 mg/kg, and 0% at 2.5 mg/kg). Four pts (1 at 1.0 mg/kg and 3 at 2.0 mg/kg) had ABX-EGF dosing interrupted or reduced because of skin toxicities. The PK of ABX-EGF appeared to be dose dependent. PK results for paclitaxel were similar to that reported in the literature. Conclusions: ABX-EGF is well tolerated in combination with paclitaxel and carboplatin for advanced NSCLC. Part 2 of the study continues to accrue patients to further assess clinical activity in this setting.<<
So this mirrors the interim results. Might not move the stock much Monday, but neither should it crater. Covered write looking OK.
Cheers, Tuck, just back from Smith Rock, Oregon, and whose ears are still ringing from the small plane trip (got to do a rather shaky final approach into Palomar Airport this afternoon, but the real pilot actually put the plane down -- whew!) |
