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FDA Approvals in Breast Cancer and Hodgkin Lymphoma, 2017 SGO Highlights, and More

Brielle Urciuoli
Published Online: Friday, Mar 17, 2017



Today-

FDA approvals in breast cancer and Hodkgin lymphoma, impressive long-term findings in chronic myelogenous (mya-loj-en-us) leukemia, highlights with rucaparib from the 2017 SGO Annual Meeting, exciting potential with a triple-negative breast cancer treatment, and a partial clinical hold placed on selinexor trials.

Welcome to OncLive News Network! I’m Brielle Urciuoli.

The FDA has approved ribociclib (RYE-bow-SICK-lib) for use in combination with an aromatase inhibitor for the frontline treatment of postmenopausal women with hormone-receptor–positive, HER2-negative advanced breast cancer.

The decision is based on findings from the phase III MONALEESA-2 trial, in which combining the CDK 4/6 inhibitor with letrozole reduced the risk of progression or death by 44% versus letrozole alone.

In MONALEESA-2 trial, the ribociclib group’s median progression-free survival had yet to be reached at a median follow-up of 15.3 months. However, the placebo group had an estimated median PFS of 14.7 months. Moreover, a blinded PFS assessment by an independent review committee resulted in a hazard ratio of 0.59 in favor of the ribociclib arm.

After 11 more months of follow-up, an analysis showed that the median PFS was 25.3 months with the ribociclib combination versus 16 months with letrozole alone. Overall survival data are still not mature.

******************************************************************************************************************

The FDA has also granted an accelerated approval to the PD-1 inhibitor pembrolizumab (Keytruda) for the treatment of adult and pediatric patients with classical Hodgkin lymphoma (cHL) who are refractory or have relapsed after 3 or more lines of therapy.

The approval is based on data from the nonrandomized, open-label KEYNOTE-087 trial.

At a median follow-up of 9.4 months, the overall response rate with pembrolizumab was 69%, including complete responses in 22% of patients and partial responses in 47% of patients.The median duration of response was 11.1 months among the 145 responding patients.

This is the first FDA indication for pembrolizumab in a hematologic malignancy.

In chronic myelogenous (mya-loj-en-us) leukemia, imatinib continued to show dramatic overall survival benefits after nearly 11 years of follow-up and despite crossover for patients with Philadelphia chromosome-positive disease.

The results were shown in a 10.9-year assessment of the phase III IRIS trial. Here, the 10-year OS rate was 83.3% for 400-mg imatinib. Overall, 65.6% of patients crossed over to imatinib from the control arm of interferon alfa plus cytarabine (CITE-ara-bean). The median time to crossover was 0.8 years.

The OS rate after 10 years for those treated with interferon alfa plus cytarabine was 78.8%. Despite the crossover, there was still a 26% reduction in the risk of death with imatinib.

Earlier findings from this phase III trial changed practice for patients with CML, ushering in an era of precision medicine.

******************************************************************************************************************

At the Society of Gynecologic Oncology Annual Meeting, which took place in National Harbor, Maryland this week, phase II reports of the PARP inhibitor rucaparib (Roo-CAP-a-rib) showed that the agent slowed progression of relapsed BRCA-mutant ovarian cancer regardless of whether the mutations were somatic or germline.

Patients with germline or somatic BRCA mutations had a median progression-free survival of about 13 months when treated with rucaparib.

In the ARIEL2 analysis, data also showed that patients with BRCA1 or BRCA2-mutant disease had similar PFS with the PARP inhibitor. However, patients with platinum-sensitive disease seemed to derive the most benefit from rucaparib, and PFS increased with the duration of the platinum-free interval.

The ARIEL2 trial investigated the effect of single-agent rucaparib on PFS in patients with relapsed platinum-sensitive ovarian cancer and objective response rate in patients with relapsed, heavily pretreated ovarian cancer.

******************************************************************************************************************

In triple-negative breast cancer, the combination of eribulin (ee-rib-you-lynne) plus pembrolizumab was found to have promising objective response rates, including a complete response, for patients with metastatic disease.

Results of an interim analysis of a phase Ib/II trial, which were presented at the 2017 Miami Breast Cancer Conference, showed that of the 39 evaluable patients, the ORR with the combination was 33.3%. The CR rate was 2.6% and 28.2% of patients had stable disease for at least 8 weeks, of which 7.7% was for at least 24 weeks. Moreover, the clinical benefit rate was 41%.

Longer follow-up from the trial for the full 89 patients enrolled are anticipated later this year. Additionally, a second phase II study will begin enrolling soon to assess pembrolizumab with or without eribulin for patients with hormone-receptor–positive breast cancer.

******************************************************************************************************************

And finally, the FDA has placed a partial clinical hold on trials of selinexor (sell-in-ex-OR), an agent that is being explored in several tumor types.

While the hold does halt additional enrollment in the trials, patients who have achieved stable disease or better with selinexor can continue treatment.

Karyopharm, the company developing the agent, stated that the hold is due to incomplete information in the existing version of the investigator's brochure, which includes an incomplete list of serious adverse events associated with the drug.

Moreover, the company explained that the clinical hold is not associated with any new safety concerns.

At the FDA’s request, Karyopharm has amended the IB and updated the informed consent documents accordingly. Karyopharm adds that it submitted these documents to the FDA as requested.

Now that the FDA has received the needed materials from Karyopharm, the agency will review the information and make a decision within 30 days on whether or not to lift the hold.

******************************************************************************************************************

That’s all for today.

Thank you for watching OncLive News Network! I’m Brielle Urciuoli.
 
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Today-

FDA approvals in breast cancer and Hodkgin lymphoma, impressive long-term findings in chronic myelogenous (mya-loj-en-us) leukemia, highlights with rucaparib from the 2017 SGO Annual Meeting, exciting potential with a triple-negative breast cancer treatment, and a partial clinical hold placed on selinexor trials.

Welcome to OncLive News Network! I’m Brielle Urciuoli.

The FDA has approved ribociclib (RYE-bow-SICK-lib) for use in combination with an aromatase inhibitor for the frontline treatment of postmenopausal women with hormone-receptor–positive, HER2-negative advanced breast cancer.

The decision is based on findings from the phase III MONALEESA-2 trial, in which combining the CDK 4/6 inhibitor with letrozole reduced the risk of progression or death by 44% versus letrozole alone.

In MONALEESA-2 trial, the ribociclib group’s median progression-free survival had yet to be reached at a median follow-up of 15.3 months. However, the placebo group had an estimated median PFS of 14.7 months. Moreover, a blinded PFS assessment by an independent review committee resulted in a hazard ratio of 0.59 in favor of the ribociclib arm.

After 11 more months of follow-up, an analysis showed that the median PFS was 25.3 months with the ribociclib combination versus 16 months with letrozole alone. Overall survival data are still not mature.

******************************************************************************************************************

The FDA has also granted an accelerated approval to the PD-1 inhibitor pembrolizumab (Keytruda) for the treatment of adult and pediatric patients with classical Hodgkin lymphoma (cHL) who are refractory or have relapsed after 3 or more lines of therapy.

The approval is based on data from the nonrandomized, open-label KEYNOTE-087 trial.

At a median follow-up of 9.4 months, the overall response rate with pembrolizumab was 69%, including complete responses in 22% of patients and partial responses in 47% of patients.The median duration of response was 11.1 months among the 145 responding patients.

This is the first FDA indication for pembrolizumab in a hematologic malignancy.

In chronic myelogenous (mya-loj-en-us) leukemia, imatinib continued to show dramatic overall survival benefits after nearly 11 years of follow-up and despite crossover for patients with Philadelphia chromosome-positive disease.

The results were shown in a 10.9-year assessment of the phase III IRIS trial. Here, the 10-year OS rate was 83.3% for 400-mg imatinib. Overall, 65.6% of patients crossed over to imatinib from the control arm of interferon alfa plus cytarabine (CITE-ara-bean). The median time to crossover was 0.8 years.

The OS rate after 10 years for those treated with interferon alfa plus cytarabine was 78.8%. Despite the crossover, there was still a 26% reduction in the risk of death with imatinib.

Earlier findings from this phase III trial changed practice for patients with CML, ushering in an era of precision medicine.

******************************************************************************************************************

At the Society of Gynecologic Oncology Annual Meeting, which took place in National Harbor, Maryland this week, phase II reports of the PARP inhibitor rucaparib (Roo-CAP-a-rib) showed that the agent slowed progression of relapsed BRCA-mutant ovarian cancer regardless of whether the mutations were somatic or germline.

Patients with germline or somatic BRCA mutations had a median progression-free survival of about 13 months when treated with rucaparib.

In the ARIEL2 analysis, data also showed that patients with BRCA1 or BRCA2-mutant disease had similar PFS with the PARP inhibitor. However, patients with platinum-sensitive disease seemed to derive the most benefit from rucaparib, and PFS increased with the duration of the platinum-free interval.

The ARIEL2 trial investigated the effect of single-agent rucaparib on PFS in patients with relapsed platinum-sensitive ovarian cancer and objective response rate in patients with relapsed, heavily pretreated ovarian cancer.

******************************************************************************************************************

In triple-negative breast cancer, the combination of eribulin (ee-rib-you-lynne) plus pembrolizumab was found to have promising objective response rates, including a complete response, for patients with metastatic disease.

Results of an interim analysis of a phase Ib/II trial, which were presented at the 2017 Miami Breast Cancer Conference, showed that of the 39 evaluable patients, the ORR with the combination was 33.3%. The CR rate was 2.6% and 28.2% of patients had stable disease for at least 8 weeks, of which 7.7% was for at least 24 weeks. Moreover, the clinical benefit rate was 41%.

Longer follow-up from the trial for the full 89 patients enrolled are anticipated later this year. Additionally, a second phase II study will begin enrolling soon to assess pembrolizumab with or without eribulin for patients with hormone-receptor–positive breast cancer.

******************************************************************************************************************

And finally, the FDA has placed a partial clinical hold on trials of selinexor (sell-in-ex-OR), an agent that is being explored in several tumor types.

While the hold does halt additional enrollment in the trials, patients who have achieved stable disease or better with selinexor can continue treatment.

Karyopharm, the company developing the agent, stated that the hold is due to incomplete information in the existing version of the investigator's brochure, which includes an incomplete list of serious adverse events associated with the drug.

Moreover, the company explained that the clinical hold is not associated with any new safety concerns.

At the FDA’s request, Karyopharm has amended the IB and updated the informed consent documents accordingly. Karyopharm adds that it submitted these documents to the FDA as requested.

Now that the FDA has received the needed materials from Karyopharm, the agency will review the information and make a decision within 30 days on whether or not to lift the hold.

******************************************************************************************************************

That’s all for today.

Thank you for watching OncLive News Network! I’m Brielle Urciuoli.
 
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