Tag: Idelalisib

New Options for Treating Patients with Ibrutinib Resistant Mantle Cell Lymphoma

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.

Zydelig Approved by FDA for Patients with CLL, FL, & SLL

Earlier this afternoon the FDA announced the approval of Zydelig (idelalisib) for patients with relapsed chronic lymphocytic leukemia (CLL). Accelerated approval was also granted for the use of  Zydelig in patients with relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic lymphoma (SLL). According to the FDA press release:

“Zydelig’s safety and effectiveness to treat relapsed CLL were established in a clinical trial of 220 participants who were randomly assigned to receive Zydelig and Rituxan or placebo and Rituxan. The trial was stopped for efficacy following the first pre-specified interim analysis point, which showed participants treated with Zydelig and Rituxan lived 10.7 months without their disease progressing (progression-free survival) compared to about 5.5 months for participants treated with placebo and Rituxan. Results from a second interim analysis continued to show a statistically significant improvement for Zydelig and Rituxan over placebo and Rituxan.”

…

“Zydelig’s safety and effectiveness to treat relapsed FL and relapsed SLL were established in a clinical trial with 123 participants with slow-growing (indolent) non-Hodgkin lymphomas. All participants were treated with Zydelig and were evaluated for complete or partial disappearance of their cancer after treatment (objective response rate, or ORR). Results showed 54 percent of participants with relapsed FL and 58 percent of participants with SLL experienced ORR.”

Commenting on this welcomed development Dr. Richard Furman said, “We are very excited to have idelalisib to add to our armentarium of agents that are now available for use and would like to thank all of the patients and their families who made this possible by participating in the clinical trials.” Look to this blog and our clinical trials page for further developments regarding the use of Zydelig in the treatment of CLL, FL, & SLL patients.

Two Newly Opened Clinical Trials Evaluate Idelalisib in Indolent non-Hodgkin Lymphoma

The Weill Cornell Lymphoma Program has recently opened two clinical trials evaluating the experimental drug idelalisib in previously treated indolent non-Hodgkin lymphomas (iNHL). The sponsor of the trials is Gilead Sciences.  The principal investigator at Weill Cornell is Dr. Peter Martin. For more information about the studies please call Amelyn Rodriguez, RN at (212) 746-1362 or e-mail Amelyn at amr2017@med.cornell.edu.

Idelalisib (GS-1101, previously CAL-101) works by blocking some of the cell functions that cause iNHL to grow and survive.

Gilead 0124: Idelalisib in Combination With Rituximab 

This study evaluates the effectiveness of idelalisib combined with rituximab in treating iNHL. Rituximab is FDA-approved for treating iNHL. It is possible that giving rituximab together with idelalisib may have more activity against iNHL than giving rituximab alone.

Key Eligibility

  • Men and women age 18 and older
  • B-cell indolent non-Hodgkin lymphoma (iNHL)
  • Have received prior therapy containing anti-CD20 antibody
  • iNHL is not refractory to rituximab

Click here for a detailed summary of this trial.

Gilead 0125: Idelalisib in Combination With Bendamustine and Rituximab

Update: this study is closed to enrollment. 

This study evaluates the effectiveness of idelalisib combined with bendamustine and rituximab. Rituximab and bendamustine are FDA-approved for treating iNHL. It is possible that giving rituximab and bendamustine together with idelalisib is more effective in treating iNHL than giving rituximab and bendamustine alone.

Key Eligibility

  • Men and women age 18 and older
  • B-cell indolent non-Hodgkin lymphoma
  • Have received prior therapy containing anti-CD20 antibody and chemotherapy
  • iNHL is not refractory to bendamustine

Click here for a detailed summary of this trial.