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Priority Reviews in Prostate and Bladder Cancer, NCCN CRC Guidelines Update, and More

Gina Columbus
Published: Friday, Mar 23, 2018



Today-

A priority review designation in prostate cancer, a breakthrough therapy designation in bladder cancer, promising phase III findings in lung cancer, an addition to the NCCN Colorectal Cancer Guidelines, and a decision made by the CMS for genomic testing.

Welcome to OncLive News Network! I’m Gina Columbus.

The FDA has granted a priority review to a supplemental new drug application for enzalutamide for the treatment of men with nonmetastatic castration-resistant prostate cancer.

The sNDA is based on findings from the phase III PROSPER trial in which the combination of enzalutamide and androgen deprivation therapy reduced the risk of metastases or death by 71% versus ADT alone for patients with nonmetastatic CRPC.

In the double-blind study, the median metastasis-free survival was 36.6 months with enzalutamide plus ADT compared with 14.7 months with ADT alone. Additionally, there was a 93% reduction in the risk of PSA progression in the enzalutamide arm versus ADT alone. The median time to PSA progression in the enzalutamide group was 37.2 months versus 3.9 months for ADT alone.

Under the Prescription Drug User Fee Act, the FDA is scheduled to make its decision by July 2018.

The FDA initially approved enzalutamide as a treatment for men with metastatic CRPC after docetaxel therapy in 2012. This indication was expanded to include treatment in combination with the antiandrogen prior to chemotherapy in 2014.

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In urothelial carcinoma, the FDA has granted a breakthrough therapy designation to erdafitinib for the treatment of patients with metastatic disease.

The designation is based on the global phase II BLC200 study, in which the oral pan-FGFR tyrosine kinase inhibitor induced a 42% overall response rate in 59 patients with FGFR-positive relapsed/refractory metastatic urothelial carcinoma.

The study evaluated the ORR in patients with pretreated metastatic or unresectable FGFR alteration–positive disease who received 1 of 3 doses of erdafitinib. Across all doses, the ORR was 35% and the confirmed disease control rate was 76%. Moreover, the median progression-free survival across all dosing cohorts was 5.1 months.

Investigators found that 75% of patients treated with 8 mg of continuous erdafitinib saw a reduction in the sum of target lesion diameters, regardless of the kind of gene alterations.

The FDA’s decision will expedite the review and development of erdafitinib.

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Phase III results of the IMpower131 trial demonstrated that the addition of atezolizumab to frontline carboplatin and nab-paclitaxel delayed progression or death versus chemotherapy alone for patients with advanced squamous non–small cell lung cancer.

Roche, the manufacturer of the PD-L1 inhibitor, reported that the full findings will be presented at an upcoming medical meeting. However, they did state that a statistically significant overall survival improvement was not observed at the interim analysis and the study is now continuing according to its design. The coprimary endpoints for IMpower131 were progression-free survival and OS. 

The study randomized 1021 chemotherapy-naïve patients with stage IV squamous NSCLC to upfront treatment with atezolizumab, carboplatin, and paclitaxel; atezolizumab, carboplatin, and nab-paclitaxel; or the control arm of carboplatin and nab-paclitaxel.

No new safety signals emerged with the atezolizumab regimen.

Previous results of a phase Ib trial of atezolizumab with chemotherapy showed that 26 of 41 evaluable patients met the criteria for objective response, and 4 of 8 patients in the atezolizumab plus carboplatin/paclitaxel cohort achieved objective responses. The combination of atezolizumab, carboplatin, and pemetrexed induced a response in 13 of 17 patients. Responses also occurred in 9 of 16 patients who received carboplatin and nab-paclitaxel in addition to atezolizumab. 

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The NCCN has updated its colorectal cancer guidelines to recommend a weekly regorafenib dose-escalation strategy beginning at 80 mg and ending at 160 mg for previously treated patients with metastatic CRC.

This new dosing scheme calls for a starting dose of 80 mg/daily on days 1 to 7, escalating to 120 mg/daily on days 8 to 14, and concluding with 160 mg/daily on days 15 to 21. For subsequent cycles, the NCCN recommends 160 mg of regorafenib on days 1 to 21 every 28 days.

The updated results are based on findings from the phase II regorafenib dose optimization ReDOS study, which compared the dose escalation regimen with the standard dose of regorafenib daily. The median overall survival was 9.0 months in the dose-escalation arm versus 5.9 months in the standard arm.

The 6-month OS rate was 66.5% in the escalation arm versus 49.8% in the standard arm. Twelve-month OS also favored the dose escalation arm at 34.4% versus 26.7%.

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

The Centers for Medicare & Medicaid Services has announced that it will cover diagnostic laboratory tests using Next Generation Sequencing for patients with advanced cancer.

In a national coverage determination issued March 16, CMS said it will approve coverage of genomic testing for patients with recurrent, metastatic, relapsed, refractory, or stages III/IV cancer. The agency said such tests can help patients and physicians make more informed treatment decisions.

CMS issued a proposed draft guidance for NGS testing in November when the FoundationOne CDx test won simultaneous FDA approval and CMS coverage.

Overall, the decision means that CMS will cover FDA-approved or cleared in vitro NGS diagnostics when the test has a companion FDA approved or cleared treatment option, and results are provided to the treating physician for management of the patient using a report template to specify treatment options.

Medicare Administrative Contractors may determine local coverage of other NGS tests as a diagnostic laboratory test for patients with cancer, such as MSK-IMPACT. The decision also provides coverage for repeat testing when a Medicare patient has a new primary diagnosis of cancer.

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

This week, we sat down with Dr Jonathan Rosenberg, of Memorial Sloan Kettering Cancer Center, to discuss the promise of DNA vaccines in bladder cancer.

That’s all for today.

Thank you for watching OncLive News Network! I’m Gina Columbus.
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Today-

A priority review designation in prostate cancer, a breakthrough therapy designation in bladder cancer, promising phase III findings in lung cancer, an addition to the NCCN Colorectal Cancer Guidelines, and a decision made by the CMS for genomic testing.

Welcome to OncLive News Network! I’m Gina Columbus.

The FDA has granted a priority review to a supplemental new drug application for enzalutamide for the treatment of men with nonmetastatic castration-resistant prostate cancer.

The sNDA is based on findings from the phase III PROSPER trial in which the combination of enzalutamide and androgen deprivation therapy reduced the risk of metastases or death by 71% versus ADT alone for patients with nonmetastatic CRPC.

In the double-blind study, the median metastasis-free survival was 36.6 months with enzalutamide plus ADT compared with 14.7 months with ADT alone. Additionally, there was a 93% reduction in the risk of PSA progression in the enzalutamide arm versus ADT alone. The median time to PSA progression in the enzalutamide group was 37.2 months versus 3.9 months for ADT alone.

Under the Prescription Drug User Fee Act, the FDA is scheduled to make its decision by July 2018.

The FDA initially approved enzalutamide as a treatment for men with metastatic CRPC after docetaxel therapy in 2012. This indication was expanded to include treatment in combination with the antiandrogen prior to chemotherapy in 2014.

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

In urothelial carcinoma, the FDA has granted a breakthrough therapy designation to erdafitinib for the treatment of patients with metastatic disease.

The designation is based on the global phase II BLC200 study, in which the oral pan-FGFR tyrosine kinase inhibitor induced a 42% overall response rate in 59 patients with FGFR-positive relapsed/refractory metastatic urothelial carcinoma.

The study evaluated the ORR in patients with pretreated metastatic or unresectable FGFR alteration–positive disease who received 1 of 3 doses of erdafitinib. Across all doses, the ORR was 35% and the confirmed disease control rate was 76%. Moreover, the median progression-free survival across all dosing cohorts was 5.1 months.

Investigators found that 75% of patients treated with 8 mg of continuous erdafitinib saw a reduction in the sum of target lesion diameters, regardless of the kind of gene alterations.

The FDA’s decision will expedite the review and development of erdafitinib.

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

Phase III results of the IMpower131 trial demonstrated that the addition of atezolizumab to frontline carboplatin and nab-paclitaxel delayed progression or death versus chemotherapy alone for patients with advanced squamous non–small cell lung cancer.

Roche, the manufacturer of the PD-L1 inhibitor, reported that the full findings will be presented at an upcoming medical meeting. However, they did state that a statistically significant overall survival improvement was not observed at the interim analysis and the study is now continuing according to its design. The coprimary endpoints for IMpower131 were progression-free survival and OS. 

The study randomized 1021 chemotherapy-naïve patients with stage IV squamous NSCLC to upfront treatment with atezolizumab, carboplatin, and paclitaxel; atezolizumab, carboplatin, and nab-paclitaxel; or the control arm of carboplatin and nab-paclitaxel.

No new safety signals emerged with the atezolizumab regimen.

Previous results of a phase Ib trial of atezolizumab with chemotherapy showed that 26 of 41 evaluable patients met the criteria for objective response, and 4 of 8 patients in the atezolizumab plus carboplatin/paclitaxel cohort achieved objective responses. The combination of atezolizumab, carboplatin, and pemetrexed induced a response in 13 of 17 patients. Responses also occurred in 9 of 16 patients who received carboplatin and nab-paclitaxel in addition to atezolizumab. 

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

The NCCN has updated its colorectal cancer guidelines to recommend a weekly regorafenib dose-escalation strategy beginning at 80 mg and ending at 160 mg for previously treated patients with metastatic CRC.

This new dosing scheme calls for a starting dose of 80 mg/daily on days 1 to 7, escalating to 120 mg/daily on days 8 to 14, and concluding with 160 mg/daily on days 15 to 21. For subsequent cycles, the NCCN recommends 160 mg of regorafenib on days 1 to 21 every 28 days.

The updated results are based on findings from the phase II regorafenib dose optimization ReDOS study, which compared the dose escalation regimen with the standard dose of regorafenib daily. The median overall survival was 9.0 months in the dose-escalation arm versus 5.9 months in the standard arm.

The 6-month OS rate was 66.5% in the escalation arm versus 49.8% in the standard arm. Twelve-month OS also favored the dose escalation arm at 34.4% versus 26.7%.

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

The Centers for Medicare & Medicaid Services has announced that it will cover diagnostic laboratory tests using Next Generation Sequencing for patients with advanced cancer.

In a national coverage determination issued March 16, CMS said it will approve coverage of genomic testing for patients with recurrent, metastatic, relapsed, refractory, or stages III/IV cancer. The agency said such tests can help patients and physicians make more informed treatment decisions.

CMS issued a proposed draft guidance for NGS testing in November when the FoundationOne CDx test won simultaneous FDA approval and CMS coverage.

Overall, the decision means that CMS will cover FDA-approved or cleared in vitro NGS diagnostics when the test has a companion FDA approved or cleared treatment option, and results are provided to the treating physician for management of the patient using a report template to specify treatment options.

Medicare Administrative Contractors may determine local coverage of other NGS tests as a diagnostic laboratory test for patients with cancer, such as MSK-IMPACT. The decision also provides coverage for repeat testing when a Medicare patient has a new primary diagnosis of cancer.

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

This week, we sat down with Dr Jonathan Rosenberg, of Memorial Sloan Kettering Cancer Center, to discuss the promise of DNA vaccines in bladder cancer.

That’s all for today.

Thank you for watching OncLive News Network! I’m Gina Columbus.
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Community Practice Connections™: 18th Annual International Lung Cancer Congress®Oct 31, 20181.5
Provider and Caregiver Connection™: Addressing Patient Concerns While Managing Chemotherapy Induced Nausea and VomitingOct 31, 20182.0
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