May be MEK inhibition in cell lines showed dismal responses but MEK inhibition with selumetinib in KRAS mutation-positive patients demonstrated 37% response rate (vs 0%) and prolonged PFS. Perhaps inhibition of both EGFR and MEK is a better strategy and will be explored in future but Phase 2 data indicate that inhibition of MEK only could be beneficial for patients.
It has a good rationale. Trial's population is KRAS mutation-positive patients. How can you say "No "driver" mutations in the MAPK pathway"? What do you know?
One more abstract
Phase 2 results: encorafenib (ENCO) and cetuximab (CETUX) with or without alpelisib (ALP) in patients with advanced BRAF-mutant colorectal cancer (BRAFm CRC).
He is correct. PFS in a single arm study cannot be used for any approval, including accelerated approval. Marqibo, Folotyn and Belinostat were all approved based on response rates. When you see a response, you know that it is a drug's effect. When you see a PFS curve with no control, what do you know? Placebo will also produce a curve.
I would pay attention to what is going on with Neratinib. Compare titles for Poziotinob and Neratinib trials: "Poziotinib in Patients With HER2+ Recurrent Stage IV BC Who Have Received at Least 2 Prior HER2-directed Regimens" and "A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting". Same patient population and Puma runs a 600-patient Phase 3 study with PFS and OS as primary endpoints. I don't see how Spectrum is able to negotiate accelerated approval, especially, if the results of Neratinib trial are positive.
ASH is American Society of Hematology. Why should they accept any abstract on breast cancer? And I don't understand why everybody is so excited about Raj's excitement. He is a specialist in hematologic oncology and does not have any experience in breast cancer and HER inhibitors. We need to hear about how exciting is a new Korean data from more knowledgeable person.
Immunotherapy Puts 93 Percent of Advanced Leukemia Patients in Remission
Friday, 29 Apr 2016 12:20 PM
An astounding 93 percent of patients with advanced leukemia that was resistant to multiple other forms of therapy went into remission after their T-cells were genetically engineered to fight their cancers.
Researchers at Fred Hutchinson Cancer Research Center worked with the University of Washington Cancer Consortium to enroll patients with B-cell acute lymphoblastic leukemia. All of the patients had advanced disease that had relapsed and were immune to other therapies.
The patients received genetically engineered versions of their own T-cells — disease-fighting immune cells — with a synthetic receptor molecule called a CAR (chimeric antigen receptor) that allows T-cells to recognize and kill cancer cells that carry a specific marker called CD19.
T-cells were extracted from patients, and a specialized virus delivered the DNA instructions for making the CAR into the cells. Then, the cells were multiplied to the billions in the lab.
After chemotherapy, the reengineered cells were infused back into the patients they came from about two weeks after they were first extracted.
A few weeks after the infusion, highly sensitive tests could find no trace of cancer in the bone marrow of 27 of 29 patients. CAR T-cells eliminated cancers anywhere in the body they appeared.
Great results, do not bode well for Marqibo.
Read the comment from Barry H Kaplan to this article. It is an oncologist view on Cobi, Cabo and Opdivo. He said that "Opdivo's benefits have been outrageously overstated".