FDA Approves Combining Merck’s Keytruda With Chemotherapy in Lung Cancer Patients

Excerpt:

“U.S. health regulators approved expanding the use of Merck & Co.’s cancer drug Keytruda to include adding it to chemotherapy to treat lung cancer, broadening the drug’s potential market though evidence for the combination’s benefit is mixed.

“Keytruda, introduced in 2014, is one of a new wave of cancer drugs designed to work by harnessing the body’s own immune system to fight tumors. The U.S. Food and Drug Administration on Wednesday approved combining it with two chemotherapy agents, pemetrexed and carboplatin, to treat patients with an advanced form of lung cancer. Eli Lilly & Co. markets pemetrexed under the brand Alimta, and carboplatin is available generically.”

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tnAcity Data Presented at SABCS Evaluates the Investigational Use of ABRAXANE® as First-Line Treatment of Metastatic Triple Negative Breast Cancer

Excerpt:

“Celgene Corporation (CELG) today announced that the results of its randomized phase II tnAcity trial of ABRAXANE® for injectable suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) will be presented at the 2016 San Antonio Breast Cancer Symposium (SABCS) December 6-10, 2016. The trial found that an investigational weekly combination regimen of ABRAXANE + carboplatin had significantly longer progression-free survival (PFS) (7.4 months) compared to weekly regimens of either ABRAXANE + gemcitabine (5.4 months) or of carboplatin + gemcitabine (6.0 months) as first-line treatment of patients with metastatic triple-negative breast cancer (mTNBC).”

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I-SPY 2: Veliparib–Carboplatin Improves Complete Response Rate in Triple-Negative Breast Cancer

Excerpt:

“The addition of veliparib–carboplatin to standard chemotherapy appeared likely to improve rate of pathologic complete response among women with triple-negative breast cancer, according to results of I-SPY 2 published inThe New England Journal of Medicine.

“Researchers calculated an 88% predictive probability that the veliparib (ABT-888, AbbVie) and carboplatin combination would remain effective when added to standard chemotherapy in phase 3 confirmatory trials.”

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Comparing Combination Treatments in HER2-Positive Early Breast Cancer

Excerpt:

“In patients with HER2-positive early breast cancer, data from a phase III trial has shown a significantly higher pathological complete response (pCR) rate with neoadjuvant docetaxel plus carboplatin plus trastuzumab plus pertuzumab (TCH+P) versus trastuzumab emtansine plus pertuzumab (T-DM1+P).

“According to the results of the KRISTINE trial, the TCH+P regimen was also associated with a higher rate of breast conserving surgery. However, researchers reported that T-DM1+P had a notably better safety profile and that health-related quality of life and physical functioning were maintained longer.

“ ‘Neoadjuvant TCH+P achieved a superior pCR rate compared with T-DM1+P and was associated with a higher breast-conserving-surgery rate,’ said Sara A. Hurvitz, MD, General Internal Medicine, Hematology & Oncology, UCLA Medical Center in Santa Monica, CA. ‘However, neoadjuvant T-DM1+P had a more favorable safety profile, with lower incidence of grade 3 or greater adverse events, serious adverse events, and adverse events leading to treatment discontinuation.’ ”

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Adding Atezolizumab to Chemotherapy Shows Promise in NSCLC

“The anti–PD-L1 agent atezolizumab (MPDL3280A) was recently investigated for safety and efficacy in combination with platinum-based doublet chemotherapy in treatment-naïve patients with advanced non–small cell lung cancer (NSCLC). Results from the phase Ib study were presented at the 2015 ASCO Annual Meeting.

“The multiple-arm study looked at MPDL3280A with a different chemotherapy backbone in each arm: carboplatin plus paclitaxel (Arm C; n = 8) carboplatin plus pemetrexed (Arm D; n = 14) or carboplatin plus nab-paclitaxel (Arm E; n = 15).

“Across all arms, the overall response rate (ORR) was 67% (48%-82%), with 60% ORR (19%-92%) in Arm C (3 partial responses [PRs]), 75% (45%-93%) in Arm D (9 PRs), and 62% (33%-83%) in Arm E (6 PRs, 2 complete responses).

“Regarding the safety profile, the researchers concluded that the combination regimens were well tolerated. The most frequent all-grade adverse events included those commonly associated with chemotherapy, such as nausea (Arms C and D, 50%; Arm E, 73%), fatigue (Arm C, 38%; Arm D, 36%; Arm E, 73%) and constipation (Arm C, 25%; Arm D, 71%; Arm E, 27%).

“OncLive spoke with Stephen Liu, MD, lead author on the study and assistant professor, Division of Hematology and Oncology, Georgetown University, to better understand the results and purpose of the uniquely designed trial, and how oncologists may need to rethink trial design when investigating similar novel agents.”


ASCO 2015: Notable Reports on Prostate Cancer Treatment


This year’s American Society of Clinical Oncology (ASCO) annual meeting was short on any truly exciting developments in prostate cancer treatment. In stark contrast to other cancers, such as lung, breast, kidney, and melanoma, there were no reports of note on targeted and immunotherapies in prostate cancer. The two presentations summarized here offered new strategies in chemotherapy. Continue reading…


Study Identifies Possible New Combination Chemotherapy for Patients with Advanced Prostate Cancer

“For more than a decade, oncologists using cytotoxic chemotherapy to treat patients with advanced metastatic castration-resistant prostate cancer (mCRPC) have relied on the sequential use of single agent taxanes such as docetaxel and cabazitaxel. For example, docetaxel is commonly used as the ‘first-line’ therapy, while cabazitaxel is used as the ‘second-line’ therapy. A role for combination therapy using two or more chemotherapy agents at the same time has not been well studied. This week, however, results of a clinical trial presented at the American Society of Clinical Oncology meeting by researchers at The University of Texas MD Anderson Cancer Center may change the perspective on a role for combination chemotherapy in advanced disease.

“The study compared the effectiveness of cabazitaxel alone versus cabazitaxel combined with carboplatin – a type of platinum chemotherapy—in patients with metastatic castrate-resistant prostate cancer (mCRPC). To date, 160 men have been randomized to treatment with either the single or dual chemotherapy drug regimen. Each patient received up to 10 cycles of chemotherapy.


German Breast Group (GBG) Studies Demonstrate Subanalyses of Tumor DNA Repair Mutations Can Help Guide Treatment Selection and Predict Response in Preoperative Breast Cancer

“The German Breast Group (GBG) presented two analyses that can serve as predictors of response to treatment by further subdividing preoperative (neoadjuvant) patients with HER 2 positive breast cancer and those with triple negative breast cancer based on tumor DNA repair capabilities and related factors.

“Prof. Dr. Gunter von Minckwitz, president of the GBG Research Institute, noted, ‘Taken together these studies demonstrate that a deeper understanding of the variations among breast cancer types that go beyond hormone response and BRCA gene mutations can inform treatment options with increased precision.’

“One study (Abstract No: 1004) fromlead author Dr. von Minckwitz found cancer-related BRCA mutations in the tumor are more common (30.3%) than inherited BRCA mutations (19.8%) in patients with triple-negative breast cancer. The homologous recombination (HR) assay measures DNA repair capacity beyond those related to BRCA mutation. HR deficiency defined as having either a BRCA mutation of the tumor or a high HR score was found in 70.5% of the patients. These findings can affect treatment options. Patients with a tumor BRCA mutation and/or a high HR score showed a high complete response to preoperative (neoadjuvant) chemotherapy. Our findings suggest those patients are also benefiting more from the additional use of carboplatin than tumors without HR deficiency.”


AbbVie Presents Phase 2 Results from Study of Investigational Medicine Veliparib in Patients with Non-Small Cell Lung Cancer at the American Society of Clinical Oncology Annual Meeting

“AbbVie (ABBV), a global biopharmaceutical company, today announced findings from a Phase 2 study of the investigational medicine veliparib combined with the chemotherapy regimen carboplatin and paclitaxel that showed an improvement in median progression-free survival (PFS) in patients with previously untreated metastatic or advanced non-small cell lung cancer (NSCLC) who are current smokers. These data will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting on June 1 in Chicago. Veliparib is an investigational oral poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor being evaluated for the treatment of various cancer types, including NSCLC.

” ‘The results from this study support further evaluation of this investigational regimen in advanced stage NSCLC patients with smoking history,’ said Suresh S. Ramalingam, M.D., professor of hematology and medical oncology, Emory University. ‘Veliparib showed interesting results when combined with chemotherapy in a subset of patients with smoking history.’ “