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BLA Accepted for a Biosimilar, Promising Findings in Prostate Cancer, Disappointing Data in Melanoma, and More

Kristi Rosa
Published: Saturday, Nov 23, 2019



Today-

An application accepted for a biosimilar, promising findings in a prostate cancer trial, disappointing data in a melanoma study, and European approvals in head and neck cancer and multiple myeloma.

Welcome to OncLive News Network! I'm Kristi Rosa.

The FDA has accepted a biologics license application for the proposed bevacizumab biosimilar SB8.

Phase III findings for SB8 were presented at the 2019 ESMO Congress, in which the biosimilar demonstrated similar efficacy in terms of best overall response rate risk ratio compared with reference bevacizumab in patients with metastatic or recurrent nonsquamous non–small cell lung cancer.

Results specifically showed that in the full analysis set, the best ORR was 47.6% and 42.8% with SB8 and reference bevacizumab, respectively. The risk ratio was 1.1, which was within the predefined equivalence margin.

In the per-protocol set, the best ORR was 50.1% with the biosimilar and 44.8% with bevacizumab. The risk difference was 5.3%, and the lower margin was contained within and the upper margin was outside the predefined equivalence margin.

Additionally, in the full analysis set, the median progression-free survival was 8.50 months with SB8 compared with 7.90 months with reference bevacizumab, and the median overall survival was 14.90 months and 15.80 months, respectively. The median duration of response with SB8 and bevacizumab was 5.60 months and 5.85 months, respectively.

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In prostate cancer, treatment with relugolix achieved a high rate of sustained testosterone suppression to castrate levels in patients with androgen-sensitive advanced disease, meeting the primary endpoint of the phase III HERO trial.

Findings showed that in the primary endpoint responder analysis, 96.7% of men receiving once-daily, oral relugolix achieved sustained testosterone suppression to castrate levels from weeks 5 through 48.

The data will serve as support for a new drug application to the FDA, which is anticipated to be submitted in the second quarter for 2020. Myovant Sciences, the developer of the relugolix, stated in a press release that the findings will also be included in future regulatory submissions in Europe and Japan.

Prior phase II data also demonstrated efficacy with relugolix in patients with metastatic or locally advanced prostate cancer who were deemed appropriate for ADT. The results showed that relugolix had a tolerable safety profile, and that after 24 weeks, prostate-specific antigen levels were reduced by 97.3% to a median of 0.1 ng/mL compared with 92.4% with a median 0.2 ng/mL with leuprorelin.

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The combination of nivolumab and ipilimumab did not show a statistically significant improvement in recurrence-free survival versus single-agent nivolumab as an adjuvant treatment for patients who have had complete surgical removal of stage IIIB, C, D or stage IV melanoma and whose tumors expressed PD-L1 less than 1%, missing the coprimary endpoint of the phase III CheckMate-915 trial.

The Data Monitoring Committee made a recommendation that the study continue unchanged. Additionally, the trial remains double-blinded and will continue to assess the other coprimary endpoint, which is RFS in the intent-to-treat population.

Earlier findings with the combination demonstrated a 3-year sustained relapse-free survival benefit in patients with high-risk, resected IIIC/IV melanoma. In a single-center, 40-patient study, adjuvant nivolumab combined with ipilimumab led to a 71% relapse-free survival rate at 3 years.

Single-agent nivolumab is also indicated for patients with melanoma with lymph node involvement or metastatic disease who have undergone complete resection in the adjuvant setting. Moreover, ipilimumab monotherapy is approved by the FDA for the adjuvant treatment of patients with stage III melanoma with pathologic involvement of regional lymph nodes larger than 1 mm who have undergone complete resection including total lymphadenectomy, and also for patients with unresectable or metastatic melanoma in adult and pediatric patients.

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

The European Commission has approved pembrolizumab as a single agent or in combination with platinum and 5-FU chemotherapy for the frontline treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma and PD-L1 expression.

The approval is based on results from the phase III KEYNOTE-048 trial, in which single-agent pembrolizumab demonstrated a 26% reduction in the risk of death compared with the standard EXTREME regimen, which comprises cetuximab with carboplatin or cisplatin plus 5-FU, in patients with PD-L1–positive tumors.

When used in combination with chemotherapy, the PD-1 inhibitor led to a 35% reduction in the risk of death. Both OS improvements were observed in patients whose tumors have PD-L1 expression.

With the European approval, pembrolizumab as a single agent and in combination for this indication will be available for use in all 28 European Union member states plus Iceland, Lichtenstein, and Norway.

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

In multiple myeloma, the European Commission has approved the triplet regimen of daratumumab with lenalidomide and dexamethasone, known as DRd, for the treatment of adult patients with newly diagnosed disease who are ineligible for autologous stem cell transplant.

The approval follows a positive opinion granted in October 2019 by the European Medicines Agency’s Committee for Medicinal Products for Human Use, and is based on findings from the phase III MAIA trial. In the study, the daratumumab regimen led to a 44% reduction in the risk of disease progression or death versus lenalidomide/dexamethasone alone in transplant-ineligible patients with newly diagnosed disease.

At a median follow-up of 28 months, results also showed that the median progression-free survival for DRd has not yet been reached compared with 31.9 months for patients who received Rd alone. Moreover, DRd led to deeper responses versus Rd alone, including higher rates of a complete response or better at 48% versus 25%. The overall response rate was also higher with the triplet regimen, at 93% versus 81%, respectively.

The FDA approved the 3-drug combination of daratumumab, lenalidomide, and dexamethasone in June 2019 for use in this setting.

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

This week, we sat down with Bruce E. Johnson, MD, of Dana-Farber Cancer Institute, to discuss next steps in research for BRAF-mutant non–small cell lung cancer.

That’s all for today.

Thank you for watching OncLive News Network! I'm Kristi Rosa.
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Today-

An application accepted for a biosimilar, promising findings in a prostate cancer trial, disappointing data in a melanoma study, and European approvals in head and neck cancer and multiple myeloma.

Welcome to OncLive News Network! I'm Kristi Rosa.

The FDA has accepted a biologics license application for the proposed bevacizumab biosimilar SB8.

Phase III findings for SB8 were presented at the 2019 ESMO Congress, in which the biosimilar demonstrated similar efficacy in terms of best overall response rate risk ratio compared with reference bevacizumab in patients with metastatic or recurrent nonsquamous non–small cell lung cancer.

Results specifically showed that in the full analysis set, the best ORR was 47.6% and 42.8% with SB8 and reference bevacizumab, respectively. The risk ratio was 1.1, which was within the predefined equivalence margin.

In the per-protocol set, the best ORR was 50.1% with the biosimilar and 44.8% with bevacizumab. The risk difference was 5.3%, and the lower margin was contained within and the upper margin was outside the predefined equivalence margin.

Additionally, in the full analysis set, the median progression-free survival was 8.50 months with SB8 compared with 7.90 months with reference bevacizumab, and the median overall survival was 14.90 months and 15.80 months, respectively. The median duration of response with SB8 and bevacizumab was 5.60 months and 5.85 months, respectively.

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

In prostate cancer, treatment with relugolix achieved a high rate of sustained testosterone suppression to castrate levels in patients with androgen-sensitive advanced disease, meeting the primary endpoint of the phase III HERO trial.

Findings showed that in the primary endpoint responder analysis, 96.7% of men receiving once-daily, oral relugolix achieved sustained testosterone suppression to castrate levels from weeks 5 through 48.

The data will serve as support for a new drug application to the FDA, which is anticipated to be submitted in the second quarter for 2020. Myovant Sciences, the developer of the relugolix, stated in a press release that the findings will also be included in future regulatory submissions in Europe and Japan.

Prior phase II data also demonstrated efficacy with relugolix in patients with metastatic or locally advanced prostate cancer who were deemed appropriate for ADT. The results showed that relugolix had a tolerable safety profile, and that after 24 weeks, prostate-specific antigen levels were reduced by 97.3% to a median of 0.1 ng/mL compared with 92.4% with a median 0.2 ng/mL with leuprorelin.

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

The combination of nivolumab and ipilimumab did not show a statistically significant improvement in recurrence-free survival versus single-agent nivolumab as an adjuvant treatment for patients who have had complete surgical removal of stage IIIB, C, D or stage IV melanoma and whose tumors expressed PD-L1 less than 1%, missing the coprimary endpoint of the phase III CheckMate-915 trial.

The Data Monitoring Committee made a recommendation that the study continue unchanged. Additionally, the trial remains double-blinded and will continue to assess the other coprimary endpoint, which is RFS in the intent-to-treat population.

Earlier findings with the combination demonstrated a 3-year sustained relapse-free survival benefit in patients with high-risk, resected IIIC/IV melanoma. In a single-center, 40-patient study, adjuvant nivolumab combined with ipilimumab led to a 71% relapse-free survival rate at 3 years.

Single-agent nivolumab is also indicated for patients with melanoma with lymph node involvement or metastatic disease who have undergone complete resection in the adjuvant setting. Moreover, ipilimumab monotherapy is approved by the FDA for the adjuvant treatment of patients with stage III melanoma with pathologic involvement of regional lymph nodes larger than 1 mm who have undergone complete resection including total lymphadenectomy, and also for patients with unresectable or metastatic melanoma in adult and pediatric patients.

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

The European Commission has approved pembrolizumab as a single agent or in combination with platinum and 5-FU chemotherapy for the frontline treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma and PD-L1 expression.

The approval is based on results from the phase III KEYNOTE-048 trial, in which single-agent pembrolizumab demonstrated a 26% reduction in the risk of death compared with the standard EXTREME regimen, which comprises cetuximab with carboplatin or cisplatin plus 5-FU, in patients with PD-L1–positive tumors.

When used in combination with chemotherapy, the PD-1 inhibitor led to a 35% reduction in the risk of death. Both OS improvements were observed in patients whose tumors have PD-L1 expression.

With the European approval, pembrolizumab as a single agent and in combination for this indication will be available for use in all 28 European Union member states plus Iceland, Lichtenstein, and Norway.

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

In multiple myeloma, the European Commission has approved the triplet regimen of daratumumab with lenalidomide and dexamethasone, known as DRd, for the treatment of adult patients with newly diagnosed disease who are ineligible for autologous stem cell transplant.

The approval follows a positive opinion granted in October 2019 by the European Medicines Agency’s Committee for Medicinal Products for Human Use, and is based on findings from the phase III MAIA trial. In the study, the daratumumab regimen led to a 44% reduction in the risk of disease progression or death versus lenalidomide/dexamethasone alone in transplant-ineligible patients with newly diagnosed disease.

At a median follow-up of 28 months, results also showed that the median progression-free survival for DRd has not yet been reached compared with 31.9 months for patients who received Rd alone. Moreover, DRd led to deeper responses versus Rd alone, including higher rates of a complete response or better at 48% versus 25%. The overall response rate was also higher with the triplet regimen, at 93% versus 81%, respectively.

The FDA approved the 3-drug combination of daratumumab, lenalidomide, and dexamethasone in June 2019 for use in this setting.

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

This week, we sat down with Bruce E. Johnson, MD, of Dana-Farber Cancer Institute, to discuss next steps in research for BRAF-mutant non–small cell lung cancer.

That’s all for today.

Thank you for watching OncLive News Network! I'm Kristi Rosa.
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