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2017 ASCO Annual Meeting Highlights, Priority Reviews in AML and RCC, and the Giants of Cancer Care

Gina Columbus
Published: Friday, Jun 09, 2017



Today-

Highlights from the 2017 ASCO Annual Meeting, FDA priority reviews granted in acute myeloid leukemia and renal cell carcinoma, an ODAC hearing for a CAR T-cell therapy in acute lymphoblastic leukemia, and the announcement of the 2017 OncLive Giants of Cancer Care.

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

At this year’s ASCO Annual Meeting, oncologists from all over the globe gathered in Chicago to hear the latest research in the field. Here are some of the key studies that were presented.

First, the addition of the CDK4/6 inhibitor abemaciclib to fulvestrant reduced the risk of disease progression or death by 45% versus fulvestrant alone in pretreated patients with hormone receptor-positive/HER2-negative breast cancer as seen in the international, double-blind phase III MONARCH 2 trial that was presented at the meeting.

Results showed that the addition of abemaciclib led to an improvement in progression-free survival of 7.1-months. The overall response rates among patients with measurable disease were 48.1% and 21.3% in the abemaciclib and control arms, respectively.

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

In multiple myeloma, phase I findings from a Chinese study on treatment chimeric antigen receptor T cells targeting B-cell maturation protein showed that 94% of patients experienced a complete remission.

Of the 19 patients who have been followed for a minimum of 4 months, 14 have reached stringent complete response criteria, 1 patient has experienced partial response, and 4 others have achieved very good partial remission.

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

The frontline combination of pembrolizumab pemetrexed, and carboplatin reduced the risk of progression or death by 50% and nearly doubled objective response rates versus chemotherapy alone for patients with advanced non-squamous non–small cell lung cancer.

Data from cohort G of the KEYNOTE-021 trial showed that after 14.5 months of follow-up, the median progression-free survival was not yet reached in the pembrolizumab arm versus 8.9 months with chemotherapy alone. The 12-month PFS rate was 56% in the pembrolizumab arm compared with 34% with chemotherapy alone, and the ORR with pembrolizumab was 56.7% compared with 30.2% for chemotherapy alone.

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

And pembrolizumab continued to show promising signs of clinical activity as a treatment for patients with advanced gastric or gastroesophageal junction cancer in updated findings from the KEYNOTE-059 study presented at the 2017 ASCO Annual Meeting.

The objective response rate with pembrolizumab was 11.6%. In those who specifically received 2 prior lines of therapy, the ORR was 16.4%. The median progression-free survival was 2.0 months and the median overall survival was 5.6 months, with a 12-month OS rate of 23.4%.

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

Also at the meeting, 3 out of 4 patients representing a range of TRK fusion–positive solid tumors responded to the novel pan-TRK inhibitor larotrectinib, also known as LOXO-101, and remain on treatment. The findings set the stage for the well-tolerated oral agent to become a standard of care for adults and children with any advanced tumor harboring this mutation.

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

Moreover, first-line treatment with lenvatinib improved progression-free survival by 3.7 months and was noninferior for overall survival compared with sorafenib for patients with unresectable hepatocellular carcinoma.

In the open-label REFLECT or Study 304 study, the median OS with lenvatinib was 13.6 months compared with 12.3 months for sorafenib, the current standard of care, and the median PFS with lenvatinib was 7.4 versus 3.7 months with sorafenib.

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

The benefit with frontline treatment with ribociclib plus letrozole was sustained in an update of the MONALEESA-2 study. The agent improved progression-free survival by 9.3 months versus letrozole plus placebo for patients with postmenopausal HR-positive, HER2-negative advanced breast cancer.

After a median follow-up of 26.4 months, the median PFS was 16.0 months with letrozole plus placebo compared with 25.3 months for ribociclib and letrozole, representing a 43% reduction in the risk of progression or death with the addition of the CDK4/6 inhibitor. The 24-month PFS rate was 54.7% with ribociclib versus 35.9% for placebo.

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

Finally, out of the ASCO Annual Meeting, the second-generation EGFR inhibitor dacomitinib, reduced the risk of disease progression by more than 40% and resulted in an average 6.5-month improvement in response duration compared with gefitinib as a first-line treatment for patients with advanced, EGFR-mutant non–small cell lung cancer, according to data from the phase III ARCHER 1050 trial.

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

In other news this week, the FDA granted a priority review designation to sunitinib for use as an adjuvant therapy in patients with renal cell carcinoma who have received nephrectomy and are at high risk for recurrence.

The supplemental new drug application for sunitinib is based on findings from the phase III S-TRAC trial, in which adjuvant sunitinib prolonged disease-free survival by 1.2 years versus placebo following nephrectomy for patients with high-risk clear cell RCC.

After a median follow-up duration of 5.4 years, the median DFS was 6.8 years in the sunitinib arm compared with 5.6 years with placebo arm. In higher risk patients, the median DFS was 6.2 versus 4.0 years for sunitinib and placebo, respectively.

The FDA is scheduled to make its final decision by January 2018.

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

In acute myeloid leukemia, the FDA accepted a new drug application from Jazz Pharmaceuticals, granting priority review to the company’s novel CPX-351 injection.

CPX-351 is an investigational nano-scale liposome co-formulation of cytarabine and daunorubicin at a synergistic 5:1 molar ratio.

The decision was based on phase III results, which showed that CPX-351 reduced the risk of death by 31% compared with 7+3 for older patients with high-risk, secondary AML. The formulation showed a median overall survival of 9.56 months versus 5.95 months with 7+3.

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

The FDA’s Oncologic Drugs Advisory Committee has scheduled a public hearing for July 12, 2017, to discuss a biologics license application for tisagenlecleucel-T, also known as CTL-019, for patients aged 3 to 25 years with relapsed/refractory B-cell acute lymphoblastic leukemia.

This announcement makes tisagenlecleucel-T the first CAR T-cell therapy to go into regulatory review when it won priority review status from the FDA in March. Under the priority review program, CTL-019 is under review for only 6 months compared with the standard 10-month evaluation. The accelerated review timeline also follows a breakthrough therapy designation from the FDA for CTL-019 in ALL.

The designation stems from findings of the global, phase II ELIANA study, along with a multicenter trial conducted in the United States and a single institution trial. In findings presented at the 2016 ASH Annual Meeting for the first 50 patients enrolled ELIANA, CTL-019 was associated with an 82% complete remission or CR with incomplete blood count recovery rate, the 6-month overall survival was 89%, and the disease-free survival rate was after a median follow-up of 4.3 months.

Novartis, the manufacturer of the therapy, has announced plans to request FDA approval for CTL-019 as a treatment for relapsed/refractory diffuse large B-cell lymphoma by the end of 2017. The company also plans to apply for regulatory approval in Europe.

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

Finally, OncLive announced the recipients of the 2017 Giants of Cancer Care in Chicago. This year, 12 respected healthcare professionals who are advancing the field of oncology by their contributions in research and clinical practice were inducted. The winners were announced on June 1 during an exclusive celebration at the Chicago History Museum.

This year’s Giants of Cancer Care inductees are:

In Breast Cancer, Norman Wolmark, MD, of Allegheny Health Network

In Gastrointestinal Cancer, Charles S. Fuchs, MD, MPH, of Yale Cancer

In Genitourinary Cancer Daniel P. Petrylak, MD, of Yale Cancer Center

In Hematologic Malignancies, Kanti R. Rai, MD, of The Feinstein Institute for Medical Research, Manhasset

In Immuno-Oncology, Thomas F. Gajewski, MD, PhD, of The University of Chicago Medicine, Chicago, Illinois

In Lung Cancer, David R. Gandara, MD, of the University of California Davis, Sacramento, California

In Melanoma, John M. Kirkwood, MD, of University of Pittsburgh Department of Medicine

In Pediatric Oncology, Joseph V. Simone, MD of Simone Consulting Company

In Radiation Oncology, Herman D. Suit, MD, MSc, PhD, of Harvard Cancer Center

In Scientific Advances/Drug Development, Lewis C. Cantley, PhD of Meyer Cancer Center

In Supportive Care, Hyman B. Muss, MD, of Lineberger Comprehensive Cancer Center

In Surgical Oncology, John L. Cameron, MD, of John Hopkins Medicine

Nominations are also now open for the 2018 Giants of Cancer Care. To nominate, please visit: giantsofcancercare.com/nominate

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

This week, Dr. Rajan Tilak Gupta of Duke Cancer Institute discussed imaging modalities to detect recurrent prostate cancer.

That’s all for today.

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

Highlights from the 2017 ASCO Annual Meeting, FDA priority reviews granted in acute myeloid leukemia and renal cell carcinoma, an ODAC hearing for a CAR T-cell therapy in acute lymphoblastic leukemia, and the announcement of the 2017 OncLive Giants of Cancer Care.

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

At this year’s ASCO Annual Meeting, oncologists from all over the globe gathered in Chicago to hear the latest research in the field. Here are some of the key studies that were presented.

First, the addition of the CDK4/6 inhibitor abemaciclib to fulvestrant reduced the risk of disease progression or death by 45% versus fulvestrant alone in pretreated patients with hormone receptor-positive/HER2-negative breast cancer as seen in the international, double-blind phase III MONARCH 2 trial that was presented at the meeting.

Results showed that the addition of abemaciclib led to an improvement in progression-free survival of 7.1-months. The overall response rates among patients with measurable disease were 48.1% and 21.3% in the abemaciclib and control arms, respectively.

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

In multiple myeloma, phase I findings from a Chinese study on treatment chimeric antigen receptor T cells targeting B-cell maturation protein showed that 94% of patients experienced a complete remission.

Of the 19 patients who have been followed for a minimum of 4 months, 14 have reached stringent complete response criteria, 1 patient has experienced partial response, and 4 others have achieved very good partial remission.

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

The frontline combination of pembrolizumab pemetrexed, and carboplatin reduced the risk of progression or death by 50% and nearly doubled objective response rates versus chemotherapy alone for patients with advanced non-squamous non–small cell lung cancer.

Data from cohort G of the KEYNOTE-021 trial showed that after 14.5 months of follow-up, the median progression-free survival was not yet reached in the pembrolizumab arm versus 8.9 months with chemotherapy alone. The 12-month PFS rate was 56% in the pembrolizumab arm compared with 34% with chemotherapy alone, and the ORR with pembrolizumab was 56.7% compared with 30.2% for chemotherapy alone.

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

And pembrolizumab continued to show promising signs of clinical activity as a treatment for patients with advanced gastric or gastroesophageal junction cancer in updated findings from the KEYNOTE-059 study presented at the 2017 ASCO Annual Meeting.

The objective response rate with pembrolizumab was 11.6%. In those who specifically received 2 prior lines of therapy, the ORR was 16.4%. The median progression-free survival was 2.0 months and the median overall survival was 5.6 months, with a 12-month OS rate of 23.4%.

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

Also at the meeting, 3 out of 4 patients representing a range of TRK fusion–positive solid tumors responded to the novel pan-TRK inhibitor larotrectinib, also known as LOXO-101, and remain on treatment. The findings set the stage for the well-tolerated oral agent to become a standard of care for adults and children with any advanced tumor harboring this mutation.

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

Moreover, first-line treatment with lenvatinib improved progression-free survival by 3.7 months and was noninferior for overall survival compared with sorafenib for patients with unresectable hepatocellular carcinoma.

In the open-label REFLECT or Study 304 study, the median OS with lenvatinib was 13.6 months compared with 12.3 months for sorafenib, the current standard of care, and the median PFS with lenvatinib was 7.4 versus 3.7 months with sorafenib.

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

The benefit with frontline treatment with ribociclib plus letrozole was sustained in an update of the MONALEESA-2 study. The agent improved progression-free survival by 9.3 months versus letrozole plus placebo for patients with postmenopausal HR-positive, HER2-negative advanced breast cancer.

After a median follow-up of 26.4 months, the median PFS was 16.0 months with letrozole plus placebo compared with 25.3 months for ribociclib and letrozole, representing a 43% reduction in the risk of progression or death with the addition of the CDK4/6 inhibitor. The 24-month PFS rate was 54.7% with ribociclib versus 35.9% for placebo.

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

Finally, out of the ASCO Annual Meeting, the second-generation EGFR inhibitor dacomitinib, reduced the risk of disease progression by more than 40% and resulted in an average 6.5-month improvement in response duration compared with gefitinib as a first-line treatment for patients with advanced, EGFR-mutant non–small cell lung cancer, according to data from the phase III ARCHER 1050 trial.

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

In other news this week, the FDA granted a priority review designation to sunitinib for use as an adjuvant therapy in patients with renal cell carcinoma who have received nephrectomy and are at high risk for recurrence.

The supplemental new drug application for sunitinib is based on findings from the phase III S-TRAC trial, in which adjuvant sunitinib prolonged disease-free survival by 1.2 years versus placebo following nephrectomy for patients with high-risk clear cell RCC.

After a median follow-up duration of 5.4 years, the median DFS was 6.8 years in the sunitinib arm compared with 5.6 years with placebo arm. In higher risk patients, the median DFS was 6.2 versus 4.0 years for sunitinib and placebo, respectively.

The FDA is scheduled to make its final decision by January 2018.

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

In acute myeloid leukemia, the FDA accepted a new drug application from Jazz Pharmaceuticals, granting priority review to the company’s novel CPX-351 injection.

CPX-351 is an investigational nano-scale liposome co-formulation of cytarabine and daunorubicin at a synergistic 5:1 molar ratio.

The decision was based on phase III results, which showed that CPX-351 reduced the risk of death by 31% compared with 7+3 for older patients with high-risk, secondary AML. The formulation showed a median overall survival of 9.56 months versus 5.95 months with 7+3.

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

The FDA’s Oncologic Drugs Advisory Committee has scheduled a public hearing for July 12, 2017, to discuss a biologics license application for tisagenlecleucel-T, also known as CTL-019, for patients aged 3 to 25 years with relapsed/refractory B-cell acute lymphoblastic leukemia.

This announcement makes tisagenlecleucel-T the first CAR T-cell therapy to go into regulatory review when it won priority review status from the FDA in March. Under the priority review program, CTL-019 is under review for only 6 months compared with the standard 10-month evaluation. The accelerated review timeline also follows a breakthrough therapy designation from the FDA for CTL-019 in ALL.

The designation stems from findings of the global, phase II ELIANA study, along with a multicenter trial conducted in the United States and a single institution trial. In findings presented at the 2016 ASH Annual Meeting for the first 50 patients enrolled ELIANA, CTL-019 was associated with an 82% complete remission or CR with incomplete blood count recovery rate, the 6-month overall survival was 89%, and the disease-free survival rate was after a median follow-up of 4.3 months.

Novartis, the manufacturer of the therapy, has announced plans to request FDA approval for CTL-019 as a treatment for relapsed/refractory diffuse large B-cell lymphoma by the end of 2017. The company also plans to apply for regulatory approval in Europe.

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

Finally, OncLive announced the recipients of the 2017 Giants of Cancer Care in Chicago. This year, 12 respected healthcare professionals who are advancing the field of oncology by their contributions in research and clinical practice were inducted. The winners were announced on June 1 during an exclusive celebration at the Chicago History Museum.

This year’s Giants of Cancer Care inductees are:

In Breast Cancer, Norman Wolmark, MD, of Allegheny Health Network

In Gastrointestinal Cancer, Charles S. Fuchs, MD, MPH, of Yale Cancer

In Genitourinary Cancer Daniel P. Petrylak, MD, of Yale Cancer Center

In Hematologic Malignancies, Kanti R. Rai, MD, of The Feinstein Institute for Medical Research, Manhasset

In Immuno-Oncology, Thomas F. Gajewski, MD, PhD, of The University of Chicago Medicine, Chicago, Illinois

In Lung Cancer, David R. Gandara, MD, of the University of California Davis, Sacramento, California

In Melanoma, John M. Kirkwood, MD, of University of Pittsburgh Department of Medicine

In Pediatric Oncology, Joseph V. Simone, MD of Simone Consulting Company

In Radiation Oncology, Herman D. Suit, MD, MSc, PhD, of Harvard Cancer Center

In Scientific Advances/Drug Development, Lewis C. Cantley, PhD of Meyer Cancer Center

In Supportive Care, Hyman B. Muss, MD, of Lineberger Comprehensive Cancer Center

In Surgical Oncology, John L. Cameron, MD, of John Hopkins Medicine

Nominations are also now open for the 2018 Giants of Cancer Care. To nominate, please visit: giantsofcancercare.com/nominate

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

This week, Dr. Rajan Tilak Gupta of Duke Cancer Institute discussed imaging modalities to detect recurrent prostate cancer.

That’s all for today.

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