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FDA Approval in NSCLC, Priority Review in SCLC, 2018 SABCS Highlights, and More

Gina Columbus
Published: Monday, Dec 17, 2018



Today-

An FDA approval in non–small cell lung cancer, a priority review in small cell lung cancer, disappointing findings in both head and neck cancer and small cell lung cancer trials, and highlights from the 2018 San Antonio Breast Cancer Symposium.

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

The FDA has approved atezolizumab for use in combination with bevacizumab, carboplatin, and paclitaxel, known as the ABCP regimen, for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer, an indication that excludes patients with EGFR/ALK aberrations.

The approval is based on findings from the phase III IMpower150 trial, in which ABCP reduced the risk of death by 22% compared with bevacizumab and chemotherapy in patients with advanced wild-type disease.

The median overall survival with the addition of atezolizumab was 19.2 months versus 14.7 months in the bevacizumab and chemotherapy arm. The 24-month OS rate with atezolizumab was 43% compared with 34% for bevacizumab and chemotherapy. ABCP also improved median progression-free survival at 8.5 vs 7.0 months with bevacizumab and chemotherapy, respectively.

When patients with EGFR/ALK alterations were included in the intent-to-treat population, the median OS with ABCP was 19.8 months versus 14.9 months with bevacizumab and chemotherapy. A survival benefit was also observed in patients with liver metastases.

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

In small cell lung cancer, the FDA has granted a priority review designation to a supplemental biologics license application for atezolizumab in combination with carboplatin and etoposide for the frontline treatment of patients with extensive-stage disease.

The application is based on the randomized phase III IMpower133 study, in which adding atezolizumab to standard upfront carboplatin and etoposide significantly prolonged survival in patients with extensive-stage-SCLC.

In the trial, results showed that at a median follow-up of 13.9 months, the median overall survival was 12.3 months in the atezolizumab arm versus 10.3 months in the placebo arm, which translated to a 30% reduction in the risk of death.

Additionally, the median progression-free survival was 5.2 months in the atezolizumab group compared with 4.3 months in the placebo group. Atezolizumab was also associated with a higher 6-month PFS rate at 30.9% vs. 22.4%, and a more than doubling 12-month PFS rate at 12.6% vs 5.4% versus placebo.

The FDA is expected to make a decision on the application by March 18, 2019.

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

Also, in small cell lung cancer, the phase III TAHOE trial evaluating second-line rovalpituzumab tesirine, known as Rova-T, as a treatment for patients with advanced disease stopped enrollment.

The halt was recommended by an Independent Data Monitoring Committee, which was based on a shorter overall survival reported in the Rova-T arm compared with the control arm of topotecan. For patients who are currently enrolled on TAHOE and receiving Rova-T treatment, the committee suggested that investigators and patients make individual decisions as to whether or not treatment should be continued based on patient level response.

Rova-T is an investigational antibody-drug conjugate targeting delta-like protein 3, which is expressed in more than 80% of SCLC tumors. The open-label, two-arm, randomized, phase III TAHOE trial was evaluating the efficacy, safety, and tolerability of Rova-T versus topotecan in patients with advanced or metastatic SCLC with high levels of DLL3 and who have first disease progression during or following frontline platinum-based chemotherapy.

This recommendation does not impact other ongoing Rova-T clinical trials outside of the TAHOE study.

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

In head and neck cancer, the PD-L1 inhibitor durvalumab alone and in combination with tremelimumab did not improve overall survival versus standard-of-care chemotherapy in patients with recurrent or metastatic head and neck squamous cell carcinoma who progressed on platinum-based chemotherapy, according to the phase III EAGLE trial.

This was the primary endpoint of the global, multicenter, open-label study, which randomized patients to single-agent durvalumab, durvalumab plus tremelimumab, or standard chemotherapy in patients with recurrent/metastatic HNSCC who progressed following platinum-based chemotherapy.

Beyond the primary OS endpoint, secondary endpoints included progression-free survival, objective response rate, and duration of response.

AstraZeneca, the developer of both agents, did not release specific data, but did note that there were no new safety signals with durvalumab monotherapy or the combination. The company plans to share the specific study results at an upcoming medical conference.

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

The 2018 San Antonio Breast Cancer Symposium was held last week in San Antonio, Texas, showcasing the latest findings in breast cancer treatment.

For example, results from the phase III KATHERINE study showed that ado-trastuzumab emtansine reduced the risk of invasive disease recurrence or death by 50% versus trastuzumab as an adjuvant treatment for patients with HER2-positive early disease who had residual invasive disease following neoadjuvant therapy.

Specifically, the data showed that the 3-year invasive disease-free survival rate was 88.3% with T-DM1 versus 77.0% with trastuzumab. The iDFS benefit with T-DM1 was upheld across key patient subgroups.

A second study presented at the meeting showed that chimeric antigen receptor T cells targeting the tyrosine kinase receptor ROR1 can be transferred into patients safely and the cells expand in vivo. This was part of the first in-human study of CAR T cells in patients with solid tumors, with data reported of 7 patients with ROR1-expressing triple-negative breast cancer.

In the study, post-treatment tumor biopsy revealed an influx of T cells and suggested ROR1 CAR T cells trafficked to tumor sites. However, CAR T cells developed an activated-exhausted phenotype at day 14 post infusion.

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

This week, we sat down with Dr Robert Ferris, of University of Pittsburgh Medical Center Hillman Cancer Center, to discuss the incidence and prevalence of advanced metastatic cutaneous squamous cell carcinoma.

That’s all for today.

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

An FDA approval in non–small cell lung cancer, a priority review in small cell lung cancer, disappointing findings in both head and neck cancer and small cell lung cancer trials, and highlights from the 2018 San Antonio Breast Cancer Symposium.

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

The FDA has approved atezolizumab for use in combination with bevacizumab, carboplatin, and paclitaxel, known as the ABCP regimen, for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer, an indication that excludes patients with EGFR/ALK aberrations.

The approval is based on findings from the phase III IMpower150 trial, in which ABCP reduced the risk of death by 22% compared with bevacizumab and chemotherapy in patients with advanced wild-type disease.

The median overall survival with the addition of atezolizumab was 19.2 months versus 14.7 months in the bevacizumab and chemotherapy arm. The 24-month OS rate with atezolizumab was 43% compared with 34% for bevacizumab and chemotherapy. ABCP also improved median progression-free survival at 8.5 vs 7.0 months with bevacizumab and chemotherapy, respectively.

When patients with EGFR/ALK alterations were included in the intent-to-treat population, the median OS with ABCP was 19.8 months versus 14.9 months with bevacizumab and chemotherapy. A survival benefit was also observed in patients with liver metastases.

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

In small cell lung cancer, the FDA has granted a priority review designation to a supplemental biologics license application for atezolizumab in combination with carboplatin and etoposide for the frontline treatment of patients with extensive-stage disease.

The application is based on the randomized phase III IMpower133 study, in which adding atezolizumab to standard upfront carboplatin and etoposide significantly prolonged survival in patients with extensive-stage-SCLC.

In the trial, results showed that at a median follow-up of 13.9 months, the median overall survival was 12.3 months in the atezolizumab arm versus 10.3 months in the placebo arm, which translated to a 30% reduction in the risk of death.

Additionally, the median progression-free survival was 5.2 months in the atezolizumab group compared with 4.3 months in the placebo group. Atezolizumab was also associated with a higher 6-month PFS rate at 30.9% vs. 22.4%, and a more than doubling 12-month PFS rate at 12.6% vs 5.4% versus placebo.

The FDA is expected to make a decision on the application by March 18, 2019.

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

Also, in small cell lung cancer, the phase III TAHOE trial evaluating second-line rovalpituzumab tesirine, known as Rova-T, as a treatment for patients with advanced disease stopped enrollment.

The halt was recommended by an Independent Data Monitoring Committee, which was based on a shorter overall survival reported in the Rova-T arm compared with the control arm of topotecan. For patients who are currently enrolled on TAHOE and receiving Rova-T treatment, the committee suggested that investigators and patients make individual decisions as to whether or not treatment should be continued based on patient level response.

Rova-T is an investigational antibody-drug conjugate targeting delta-like protein 3, which is expressed in more than 80% of SCLC tumors. The open-label, two-arm, randomized, phase III TAHOE trial was evaluating the efficacy, safety, and tolerability of Rova-T versus topotecan in patients with advanced or metastatic SCLC with high levels of DLL3 and who have first disease progression during or following frontline platinum-based chemotherapy.

This recommendation does not impact other ongoing Rova-T clinical trials outside of the TAHOE study.

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

In head and neck cancer, the PD-L1 inhibitor durvalumab alone and in combination with tremelimumab did not improve overall survival versus standard-of-care chemotherapy in patients with recurrent or metastatic head and neck squamous cell carcinoma who progressed on platinum-based chemotherapy, according to the phase III EAGLE trial.

This was the primary endpoint of the global, multicenter, open-label study, which randomized patients to single-agent durvalumab, durvalumab plus tremelimumab, or standard chemotherapy in patients with recurrent/metastatic HNSCC who progressed following platinum-based chemotherapy.

Beyond the primary OS endpoint, secondary endpoints included progression-free survival, objective response rate, and duration of response.

AstraZeneca, the developer of both agents, did not release specific data, but did note that there were no new safety signals with durvalumab monotherapy or the combination. The company plans to share the specific study results at an upcoming medical conference.

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

The 2018 San Antonio Breast Cancer Symposium was held last week in San Antonio, Texas, showcasing the latest findings in breast cancer treatment.

For example, results from the phase III KATHERINE study showed that ado-trastuzumab emtansine reduced the risk of invasive disease recurrence or death by 50% versus trastuzumab as an adjuvant treatment for patients with HER2-positive early disease who had residual invasive disease following neoadjuvant therapy.

Specifically, the data showed that the 3-year invasive disease-free survival rate was 88.3% with T-DM1 versus 77.0% with trastuzumab. The iDFS benefit with T-DM1 was upheld across key patient subgroups.

A second study presented at the meeting showed that chimeric antigen receptor T cells targeting the tyrosine kinase receptor ROR1 can be transferred into patients safely and the cells expand in vivo. This was part of the first in-human study of CAR T cells in patients with solid tumors, with data reported of 7 patients with ROR1-expressing triple-negative breast cancer.

In the study, post-treatment tumor biopsy revealed an influx of T cells and suggested ROR1 CAR T cells trafficked to tumor sites. However, CAR T cells developed an activated-exhausted phenotype at day 14 post infusion.

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

This week, we sat down with Dr Robert Ferris, of University of Pittsburgh Medical Center Hillman Cancer Center, to discuss the incidence and prevalence of advanced metastatic cutaneous squamous cell carcinoma.

That’s all for today.

Thank you for watching OncLive News Network! I’m Gina Columbus.
 
View Conference Coverage
Online CME Activities
TitleExpiration DateCME Credits
Oncology Briefings™: Individualizing Treatment After Second-Line Therapy for Patients With mCRCAug 29, 20191.0
Community Practice Connections™: Immunotherapeutic Strategies with the Potential to Transform Treatment for Genitourinary CancersAug 29, 20191.0
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