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FDA Approvals in HCC and Cervical Cancer, Breakthrough Designation in Lung Cancer, and More

Gina Columbus
Published: Monday, Mar 23, 2020



Today-

FDA approvals in hepatocellular carcinoma and cervical cancer, a breakthrough therapy designation in lung cancer, mixed findings in small cell lung cancer, a European approval in chronic lymphocytic leukemia, and how the novel coronavirus 2019 is impacting the schedule of oncology conferences.

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

The FDA has granted an accelerated approval to the combination of nivolumab and ipilimumab for the treatment of patients with hepatocellular carcinoma who have received prior therapy with sorafenib.

The approval is based on cohort findings from the phase I/II CheckMate-040 study, in which the combination of nivolumab and ipilimumab elicited an objective response rate of 33% in this patient population at a median follow-up of 28 months. The ORR included an 8% complete response rate and a 24% partial response rate.

Moreover, the duration of response ranged from 4.6 to 30.5+ months, with 88% of responses lasting at least 6 months, 56% lasting at least 12 months, and 31% of responses lasting at least 24 months. By blinded independent central review, the ORR using modified RECIST v1.1 criteria was 35%, with a 12% CR rate and a 22% PR rate.

The approved intravenous doses for the combination are 1 mg/kg of nivolumab and 3 mg/kg of ipilimumab.

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

In cervical cancer, the FDA has approved the CINtec PLUS Cytology test as the first biomarker-based triage test for women whose primary cervical cancer screening results are positive for the human papillomavirus using the cobas 4800 HPV Test.

The test allows clinicians to identify HPV-positive women who are more at risk of developing cervical precancers, identifying those patients who need to immediately receive additional diagnostic work.

The CINtec PLUS Cytology simultaneously detects p16 and Ki-67. When a cell expresses both of these biomarkers, there is a high likelihood that the patient has transforming HPV infections that can potentially progress to either precancer or cancer.

In making its decision, the FDA reviewed data from the registrational IMPACT trial, which evaluated the CINtec PLUS Cytology test as a triage tool in several screening scenarios among a population of more than 35,000 women. The results have not yet been published.

Roche, the developer of CINtec PLUS Cytology, stated that the test will be commercially available in the United States on a widespread basis later this year.

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

The FDA has granted a breakthrough therapy designation to JNJ-6372 for the treatment of patients with EGFR-positive metastatic non–small cell lung cancer who harbor exon 20 insertion mutations, and whose disease has progressed on or after platinum-based chemotherapy.

JNJ-6372 is defined as an EGFR-MET bispecific antibody that targets activating and resistant EGFR and MET mutations and amplifications.

The designation is supported by findings from a phase I trial, which showed that JNJ-6372 elicited preliminary responses in patients with NSCLC, including those who have relapsed EGFR-mutant disease and those with exon 20 insertions. The therapy was also found to have a manageable safety profile.

This specific patient population typically does not respond to EGFR TKIs and are said to have a worse prognosis versus those with more common EGFR mutations, such as exon 19 deletions and L858R substitution. Currently, this patient population is treated with conventional cytotoxic chemotherapy.

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

In small cell lung cancer, the combination of durvalumab with standard frontline chemotherapies led to a sustained overall survival benefit in patients with extensive-stage disease, according to results from the final analysis of the phase III CASPIAN trial.

However, the study missed its coprimary endpoint, as the combination of durvalumab with chemotherapy and tremelimumab did not induce a statistically significant improvement in OS versus standard chemotherapy alone.

No new safety signals emerged with this final analysis, and the data will be presented at an upcoming medical meeting.

Previously, based on the primary CASPIAN analysis, which showed that durvalumab plus standard-of-care chemotherapies induced a statistically significant improvement in OS versus chemotherapy alone, the FDA previously granted a priority review designation to a supplemental biologics license application for frontline durvalumab as a treatment for patients with ES-SCLC.

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

The European Commission has approved a fixed-dose combination of venetoclax and obinutuzumab for the treatment of patients with previously untreated chronic lymphocytic leukemia.

The approval is based on results from the phase III CLL14 trial, in which the combination led to a 65% reduction in the risk of disease progression or death compared with obinutuzumab plus chlorambucil in this patient population. The adverse events with the venetoclax regimen were consistent with the known safety profiles of each agent alone.

After a median follow-up of 28.1 months, the 2-year progression-free survival rate was 88.2% with venetoclax/obinutuzumab versus 64.1% for chlorambucil/obinutuzumab. The investigator-assessed median PFS was not yet reached in either arm; however, the independent review committee assessment of PFS was consistent.

Similarly, the PFS benefit was observed across subgroups, including those with TP53 deletion, mutation, or both and in patients with unmutated IGHV.

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

As the novel coronavirus 2019 continues a rapid global spread, many oncology-based organizations have either cancelled or postponed highly anticipated medical conferences that had been scheduled for the coming months in a valiant effort to protect physicians and patients from infection.

Most recently, the list of conferences that have been postponed include: the Annual European Neuroendocrine Tumor Society Conference, the European Society for Blood and Marrow Transplantation Annual Meeting, the National Comprehensive Cancer Network Annual Conference, European Congress of Radiology Annual Meeting, the 1st Translational Research Conference: Chronic Lymphocytic Leukemia, and the American Society of Preventive Oncology Conference, the last of which will be turned into a virtual meeting.

Meetings that have been cancelled include the ESMO Targeted Anticancer Therapies Congress, SGO’s Annual Meeting on Women’s Cancer, AACR Annual Meeting, the American Urological Association Annual Meeting, and the 5th St. Gallen International Gastrointestinal Cancer Conference.

Moreover, the European Society of Gynecological 2020 State of the Art Conference has been rescheduled to December 14 to 16, 2020.

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

This week, we sat down Dr. John Marshall, of Georgetown University, to discuss the revolution of personalized medicine in colorectal cancer.

That’s all for today.

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

FDA approvals in hepatocellular carcinoma and cervical cancer, a breakthrough therapy designation in lung cancer, mixed findings in small cell lung cancer, a European approval in chronic lymphocytic leukemia, and how the novel coronavirus 2019 is impacting the schedule of oncology conferences.

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

The FDA has granted an accelerated approval to the combination of nivolumab and ipilimumab for the treatment of patients with hepatocellular carcinoma who have received prior therapy with sorafenib.

The approval is based on cohort findings from the phase I/II CheckMate-040 study, in which the combination of nivolumab and ipilimumab elicited an objective response rate of 33% in this patient population at a median follow-up of 28 months. The ORR included an 8% complete response rate and a 24% partial response rate.

Moreover, the duration of response ranged from 4.6 to 30.5+ months, with 88% of responses lasting at least 6 months, 56% lasting at least 12 months, and 31% of responses lasting at least 24 months. By blinded independent central review, the ORR using modified RECIST v1.1 criteria was 35%, with a 12% CR rate and a 22% PR rate.

The approved intravenous doses for the combination are 1 mg/kg of nivolumab and 3 mg/kg of ipilimumab.

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

In cervical cancer, the FDA has approved the CINtec PLUS Cytology test as the first biomarker-based triage test for women whose primary cervical cancer screening results are positive for the human papillomavirus using the cobas 4800 HPV Test.

The test allows clinicians to identify HPV-positive women who are more at risk of developing cervical precancers, identifying those patients who need to immediately receive additional diagnostic work.

The CINtec PLUS Cytology simultaneously detects p16 and Ki-67. When a cell expresses both of these biomarkers, there is a high likelihood that the patient has transforming HPV infections that can potentially progress to either precancer or cancer.

In making its decision, the FDA reviewed data from the registrational IMPACT trial, which evaluated the CINtec PLUS Cytology test as a triage tool in several screening scenarios among a population of more than 35,000 women. The results have not yet been published.

Roche, the developer of CINtec PLUS Cytology, stated that the test will be commercially available in the United States on a widespread basis later this year.

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

The FDA has granted a breakthrough therapy designation to JNJ-6372 for the treatment of patients with EGFR-positive metastatic non–small cell lung cancer who harbor exon 20 insertion mutations, and whose disease has progressed on or after platinum-based chemotherapy.

JNJ-6372 is defined as an EGFR-MET bispecific antibody that targets activating and resistant EGFR and MET mutations and amplifications.

The designation is supported by findings from a phase I trial, which showed that JNJ-6372 elicited preliminary responses in patients with NSCLC, including those who have relapsed EGFR-mutant disease and those with exon 20 insertions. The therapy was also found to have a manageable safety profile.

This specific patient population typically does not respond to EGFR TKIs and are said to have a worse prognosis versus those with more common EGFR mutations, such as exon 19 deletions and L858R substitution. Currently, this patient population is treated with conventional cytotoxic chemotherapy.

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

In small cell lung cancer, the combination of durvalumab with standard frontline chemotherapies led to a sustained overall survival benefit in patients with extensive-stage disease, according to results from the final analysis of the phase III CASPIAN trial.

However, the study missed its coprimary endpoint, as the combination of durvalumab with chemotherapy and tremelimumab did not induce a statistically significant improvement in OS versus standard chemotherapy alone.

No new safety signals emerged with this final analysis, and the data will be presented at an upcoming medical meeting.

Previously, based on the primary CASPIAN analysis, which showed that durvalumab plus standard-of-care chemotherapies induced a statistically significant improvement in OS versus chemotherapy alone, the FDA previously granted a priority review designation to a supplemental biologics license application for frontline durvalumab as a treatment for patients with ES-SCLC.

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

The European Commission has approved a fixed-dose combination of venetoclax and obinutuzumab for the treatment of patients with previously untreated chronic lymphocytic leukemia.

The approval is based on results from the phase III CLL14 trial, in which the combination led to a 65% reduction in the risk of disease progression or death compared with obinutuzumab plus chlorambucil in this patient population. The adverse events with the venetoclax regimen were consistent with the known safety profiles of each agent alone.

After a median follow-up of 28.1 months, the 2-year progression-free survival rate was 88.2% with venetoclax/obinutuzumab versus 64.1% for chlorambucil/obinutuzumab. The investigator-assessed median PFS was not yet reached in either arm; however, the independent review committee assessment of PFS was consistent.

Similarly, the PFS benefit was observed across subgroups, including those with TP53 deletion, mutation, or both and in patients with unmutated IGHV.

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

As the novel coronavirus 2019 continues a rapid global spread, many oncology-based organizations have either cancelled or postponed highly anticipated medical conferences that had been scheduled for the coming months in a valiant effort to protect physicians and patients from infection.

Most recently, the list of conferences that have been postponed include: the Annual European Neuroendocrine Tumor Society Conference, the European Society for Blood and Marrow Transplantation Annual Meeting, the National Comprehensive Cancer Network Annual Conference, European Congress of Radiology Annual Meeting, the 1st Translational Research Conference: Chronic Lymphocytic Leukemia, and the American Society of Preventive Oncology Conference, the last of which will be turned into a virtual meeting.

Meetings that have been cancelled include the ESMO Targeted Anticancer Therapies Congress, SGO’s Annual Meeting on Women’s Cancer, AACR Annual Meeting, the American Urological Association Annual Meeting, and the 5th St. Gallen International Gastrointestinal Cancer Conference.

Moreover, the European Society of Gynecological 2020 State of the Art Conference has been rescheduled to December 14 to 16, 2020.

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

This week, we sat down Dr. John Marshall, of Georgetown University, to discuss the revolution of personalized medicine in colorectal cancer.

That’s all for today.

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