Earlier this week the FDA granted accelerated approval to palbociclib for the treatment of advanced (metastatic) breast cancer in combination with letrozole. Palbociclib selectively inhibits cyclin-dependent kinase 4 (CDK4) and 6 (CDK6), thereby suppressing tumor cell proliferation.
Over the past decade, researchers at Weill Cornell have led investigations of palbociclib in multiple myeloma and mantle cell lymphoma, including an ongoing phase I trial of palbociclib in combination with ibrutinib for patients with previously treated mantle cell lymphoma. Additional trials are planned.
Please look to this space for further updates concerning palbociclib for lymphoma patients. A full listing of available clinical trials can be found on our clinical trials page.
Earlier today the prestigious journal Cancer Discovery published the results of our program’s latest work in mantle cell lymphoma. Although previous clinical trials have demonstrated the effectiveness of ibrutinib in treating patients with mantle cell lymphoma, researchers also noted that some patient’s lymphoma developed ibrutinib resistance during treatment. Our findings revealed some insight into why this resistance occurs and offers several potential treatment strategies for patients who develop ibrutinib resistance. Based on their findings,
“…the researchers devised two treatment strategies that they tested in lymphoma cell lines. Both involve serial use of two anti-cancer drugs — the first to weaken or “prime” the cancer cells, and the second to deliver an added impact. Both use the experimental agent palbociclib (which selectively inhibits two cell-cycle promoting proteins, CDK4 and CDK6) to slow down the cancer’s growth and sensitize cells to the killing power of a second drug.”
As the study’s lead researcher, Dr. Selina Chen-Kiang commented,
“While for many patients ibrutinib represents a valuable treatment option, it has limitations, and we have been able to demonstrate how novel therapy combinations that target the cancer’s resistance pathways might possibly work better.”
These results build on years of laboratory and clinical work at WCMC, and they highlight the need for further research such as our ongoing trial with ibrutinib plus palbociclib
If you have any questions please contact us and look to our clinical trials page for our ongoing trials.
For additional information see the press release from the American Association for Cancer Research.
Palbociclib (PD 0332991) is generating significant excitement according to an April 6th online article from the New York Times. The article cites the results of a recently reported phase II trial in which women with metastatic breast cancer were randomized to receive letrozole plus palbociclib or letrozole alone. Women receiving the combination had their risk of progression cut in half compared to the group that received letrozole alone. These results come roughly one year after the FDA granted Breakthrough Therapy designation to palbociclib, which may help speed up the drug approval process.
Palbociclib is a highly specific oral drug that binds to and inhibits a specific subtype of enzymes called cyclin-dependent kinases (CDK). The same enzymes are critical to the development and progression of mantle cell lymphoma (MCL). Investigators at Weill Cornell Medical College have been leading the evaluation of palbociclib in MCL. Within the next month, we will open a phase I trial evaluating the combination of palbociclib plus ibrutinib in patients with previously treated MCL. For additional information regarding the upcoming trial or other trials in lymphoma, call Amelyn Rodriguez, RN at (212) 746-1362 or e-mail Amelyn at email@example.com.