All GLG News Analyses Filed Under: Oncology

Rash Predicts Better Outcome With Erbitux; But Will "Rash" Change Patient Care? Probably Not.

November 18, 2008

Analysis by: GLG Expert Contributor

Analysis of:Merck KGaA: Overall Survival in First-Line NSCLC Reaches 15 Months | www.drugs.com

It is important to use caution when interperting outcomes (in this case survival) in terms of post-treatment  (Erbitux) variables (rash).  It's a little like saying that patients who respond do better. Yes, it may be true that rash is an early indicator of which patients have a higher likelihood of doing well with Erbitux, but the question is how will that change physician's care of patients?  For me, the true importance of this study remains the fact that a EGFR antibody can be combined with chemotherapy differentiating the antibodies from the oral EGFR inhibitors.  Understanding these differences may help in the development of better drugs.  Importantly, Avastin in combination with chemotherapy has been approved in first line NSCLC, so the Erbitux combination needs to be seen as better for patients to be used in this setting.

Erbitux in Lung Ca- now to predict who will get the skin rash.

November 17, 2008

Analysis by: GLG Expert Contributor

Analysis of:Merck KGaA: Overall Survival in First-Line NSCLC Reaches 15 Months | www.drugs.com

"New data from pivotal FLEX study reveal that patients treated with Erbitux who develop early skin rash show median overall survival of 15 months (p<0.001)" This is the trial that showed Erbitux + chemo prolonged survival minimally when compared to chemo alone. Now we know the ones who develop a rash live significantly longer. NOW let's predict who will get the rash! 25+% percent developed a rash. Who are they?

Not a Vaccine I would Mandate

November 17, 2008

Analysis by: GLG Expert Contributor

Analysis of:Merck’s Gardasil Should Not Be Mandatory: Report | www.pharmalot.com

Sure, it is a good idea to prevent cervical cancer and genital warts, if possible. But given the relatively low frequency of cervical cancer, and the effectiveness of regular screening, this seems like a situation where the choice should be left to the individual.

Donald FlemingDivision Head of Hematology and OncologyDAVIS HEALTH SYSTEM INC

When being selective, targeted therapy will work

November 13, 2008

Analysis of:Tarceva successful as maintenance therapy | www.fiercebiotech.com

Saturn trial attempted to focus on EGFR reative patients Saturn was positive as a maintenance therapy, while concurrent was not

Roche's Tarceva offers a competitor to Lilly's Alimta

November 11, 2008

Analysis by: GLG Expert Contributor

Analysis of:Roche Says Tarceva Data Promising | online.wsj.com

Tarceva can maintain a remission in non small cell lung cancer after initial therapy with other agents. Just like Lilly's Alimta

Avastin for GBM: modest efficacy and soon to be approval

November 10, 2008

Analysis by: GLG Expert Contributor

Analysis of:Genentech Submits Application to U.S. Food and Drug Administration for Avastin in the Most Aggressive Form of Brain Cancer | www.gene.com

Genetech's Avastin have shown modest increase in progresion free survival and overall survival in patients with gliobalstoma multiforme, the most common and most agressive malignant brain tumor With such data, Avastin is expected to join Temodar as chemotherapy agent approved for this tumor with high mortality

Avastin Likely To Be Rapidly Adopted for Treatment of Glioblastoma

November 10, 2008

Analysis by: GLG Expert Contributor

Analysis of:Genentech Submits Application to U.S. Food and Drug Administration for Avastin in the Most Aggressive Form of Brain Cancer | www.gene.com

Glioblastoma (GBM) is a terrible diease with little chance of long term survival and few advancements in over the last few decades. While the recent study of Avastin in GBM was not a definitive study, data presented in the press release suggest that Avastin has clear activity in relapsed GBM patients that would normally have few available options, and it is likely that physicians will quickly begin using Avastin in treatment of this disease. 

Avastin in Glioblastomas: I believe approval will be....

November 6, 2008

Analysis by: GLG Expert Contributor

Analysis of:Genentech Submits Application to U.S. Food and Drug Administration for Avastin in the Most Aggressive Form of Brain Cancer | www.gene.com

Genetech is seeking FDA approval for use in the most malignant of brain tumors, Glioblastomas.

Optimizing EGFR targeted treatment in metastatic colorectal cancer

October 31, 2008

Analysis by: GLG Expert Contributor

Analysis of:Targeting EGFR in Colorectal Cancer | content.nejm.org

The identification of reliable biomarkers predicting EGFR- targeted therapy outcomes presents a major challenge in the treatment of colorectal cancer ( CRC). Determination of EGFR levels, currently used, are a poor predictor of response to cetuximab therapy.EGFR protein expression, gene amplification and mutation have little predictive value in colorectal cancer. KRAS mutations are present in over 30% of CRC and were shown to confer resistance to anti-EGFR monoclonal antibodies.  Karapetis et al analyzed tumors obtained in a randomized, phase 3, study evaluating the effect of cetuximab versus best supportive care on survival among patients with metastatic CRC.Tumor material was analyzed as to the mutation status of KRAS gene.KRAS mutations were associated with poor response to therapy, shorter progression- free and overall survival in patients with CRC treated with cetuximab.These results indicate the clinical relevance of KRAS mutations confirming earlier retrospective studies.

Donald FlemingDivision Head of Hematology and OncologyDAVIS HEALTH SYSTEM INC

The TKI's are building on their success

October 28, 2008

Analysis of:Phase II Trial of Sorafenib in Advanced Thyroid Cancer | jco.ascopubs.org

TKI's have been establihed in a small number of refractory solid cancers With slow migration to other venues, we are seeing new applications

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