Maintenance Pembrolizumab Benefits Certain Patients With Small Cell Lung Cancer

Excerpt:

“Improvements in OS, but not PFS, indicate that maintenance treatment with pembrolizumab may benefit a subset of patients with small cell lung cancer, and biomarkers are needed to identify individuals in whom pembrolizumab may be effective, according to findings presented at the ASCO Annual Meeting.

” ‘The standard of care for these patients – 4 to 6 cycles of platinum plus etoposide – has not changed in the United States in the last 30 years,’ Shirish Gadgeel, MD, of the Karmanos Cancer Institute in Detroit, said during a presentation. ‘Despite a high response rate with this therapy, overall outcomes for these patients are quite poor. There is a need to identify other agents that can provide benefit in these patients.’ ”

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Super Patient: Genetic Testing Gives Lisa Goldman a Targeted Treatment for Lung Cancer


In October 2013, Lisa Goldman had a dry cough that wouldn’t go away. “It was bad enough that I went to the doctor, which I don’t do very often,” she says. He ordered a chest radiograph, said her lungs were clear, prescribed codeine cough syrup, and sent her home.

But she kept coughing, so she kept coming back. On her second visit, her doctor said her airways were irritated and prescribed an inhaler and antibiotics. By her third visit, she’d begun to cough up a bit of blood, but her doctor just repeated that her airways were irritated and prescribed steroids. Continue reading…


Biothera Immunotherapy Combination Results in Tumor Reduction During Maintenance Phase of Non-Small Cell Lung Cancer Study

“The combination of the investigational cancer immunotherapy Imprime PGG and the monoclonal antibody bevacizumab achieved additional meaningful reductions in tumor burden during the maintenance phase of Biothera’s recent phase 2 clinical trial in non-small cell lung cancer (NSCLC). The new data will be released today at the European Lung Cancer Conference.

“Biothera conducted a randomized Phase 2 clinical study in non-squamous NSCLC in which Imprime PGG was administered in combination with bevacizumab and platinum-based doublet chemotherapy. After four to six cycles of treatment, patients received maintenance therapy of bevacizumab with or without Imprime PGG. Further meaningful reductions in tumor burden (>10mm) were observed in 6 (20%) of patients in the Imprime PGG group, but not in the control group.

“ ‘Patients receiving the combination of Imprime PGG and bevacizumab experienced further reduction in their tumor burden than with bevacizumab therapy alone,’ said Ada Braun, M.D., Ph.D., Biothera Chief Medical Officer. ‘These results highlight the efficacy of Imprime PGG and show the potential for continued tumor regressions on chemotherapy-free maintenance therapy for some patients.’ ”


Maintenance Sunitinib Improved PFS in Extensive-Stage SCLC

“The use of maintenance sunitinib improved progression-free survival (PFS) over placebo among patients with untreated extensive-stage small-cell lung cancer (SCLC) in a new phase II study.

“ ‘Most of the 30,000 patients newly diagnosed each year with SCLC in the United States have extensive-stage disease,’ wrote study authors led by Neal E. Ready, MD, PhD, of Duke University Medical Center in Durham, North Carolina. ‘Despite achieving good disease control initially, patients with SCLC usually experience relapse within 6 months of first-line chemotherapy and often do not respond to subsequent chemotherapy.’

“In previous studies, maintenance chemotherapy after standard platinum-based therapy did not show any overall survival benefit. The new study aimed to test whether sunitinib, a small-molecule tyrosine kinase inhibitor that inhibits VEGF receptors and other targets. Results of the new study were published online ahead of print in the Journal of Clinical Oncology.

“The study enrolled a total of 144 patients, 49 of whom progressed or did not complete induction chemotherapy; 95 patients were randomly assigned to a placebo maintenance therapy group (46 patients) or a sunitinib maintenance therapy group (49 patients), and five patients on each arm did not receive the maintenance therapy. Sunitinib patients received 37.5 mg per day until progression.”


MOLOGEN AG: Initiation of Phase III IMPALA Study with Immunotherapy MGN1703 in Colorectal Cancer

The gist: The first patient has been enrolled in a new clinical trial—a research study with volunteer patients. The goal of the trial is to test whether a new drug can keep cancer from returning (recurrence) in people who were treated for metastatic colorectal cancer. MGN1703 is an immunotherapy drug, meaning that it boosts a patient’s own immune system to fight cancer.

“MOLOGEN AG has enrolled the first patient in the international IMPALA study. Primary objective of the phase III pivotal trial is to prove that a switch maintenance therapy with the cancer immunotherapy MGN1703 leads to an increased overall survival (OS) in patients with metastatic colorectal carcinoma.

“IMPALA is a randomized, international, multicenter and controlled phase III trial expected to recruit about 540 patients from more than 100 European centers in eight European countries, including the five major pharma markets. The primary endpoint is overall survival. Secondary study endpoints include progression-free survival, Quality of Life (QoL) as well as safety and tolerability.

“ We are pleased that we have already enrolled the first patient in the IMPALA trial. We are excited to learn more about the efficacy of the novel immunotherapy MGN1703,’ said Prof. David Cunningham, MD, Department of Medicine and Director of Clinical Research, Royal Marsden Hospital in London. ‘The trial aims to confirm the trend in overall survival along with very good safety and tolerability of MGN1703 as observed in the IMPACT trial.’ ”


Olaparib Maintenance for Ovarian Cancer Most Effective in Women with BRCA Mutations

Editor’s note: After initial treatment, some cancer patients receive maintenance therapy to keep their cancer from returning. In a recent clinical trial with volunteer patients, scientists tested the effectiveness of maintenance therapy for platinum-sensitive recurrent serous ovarian cancer. Some of the women had BRCA1 or BRCA2 mutations, and some did not. Also, all of the women had previously been treated with platinum-based chemotherapy, and experienced tumor shrinkage or complete disappearance of their tumors. In the clinical trial, scientists randomly divided the women into two groups. One group received maintenance therapy with the drug olaparib, and for comparison, the other group was treated with a “fake” placebo drug. The scientists found that women with BRCA1 or BRCA2 mutations were more likely to benefit from the maintenance therapy treatment than women without BRCA mutations.

“Women with platinum-sensitive recurrent serous ovarian cancer who harbored BRCA mutations are more likely than BRCA wild-type patients to benefit from maintenance monotherapy with olaparib, results of a phase 2 study suggest.

“ ‘To our knowledge, our study is the first phase 2 trial in ovarian cancer to show that patients with BRCA1 or BRCA2 mutations respond preferentially to a PARP inhibitor,’ Jonathan Ledermann, MD, of UCL Cancer Institute at University College London, and colleagues wrote.

“Ledermann and colleagues conducted a randomized, double blind study that included 265 women with platinum-sensitive recurrent serous ovarian cancer. All patients received at least two platinum-based regimens and demonstrated a complete or partial response to their most recent platinum-based regimen.”


Hint of Survival Benefit with Bevacizumab-Pemetrexed Maintenance for NSCLC

“Updated data from the phase III AVAPERL trial hint that there might be an overall survival (OS) benefit of using bevacizumab in combination with pemetrexed as maintenance therapy in patients with advanced nonsmall cell lung cancer (NSCLC).

“ ‘The AVAPERL study was not powered to detect differences in OS between treatment arms’, Fabrice Barlesi, of Aix Marseille University in France, and colleagues observe in the Annals of Oncology.

“ ‘The analysis revealed, however, that OS was numerically increased by nearly 4 months in patients treated with maintenance bevacizumab-pemetrexed as compared with bevacizumab alone’, the international team of researchers reports.”

Editor’s Note: Maintenance therapy is “treatment that is given to help keep cancer from coming back after it has disappeared following the initial therapy. It may include treatment with drugs, vaccines, or antibodies that kill cancer cells, and it may be given for a long time,” according to the National Cancer Institute. Patients in this study were found to have longer survival times when taking a combination of the drugs bevacizumab and pemetrexed as a maintenance therapy than when taking bevacizumab alone.


Erbitux-Avastin Combination Plus Chemotherapy in Lung Cancer Is Safe and Effective

Combining cetuximab (Erbitux), bevacizumab (Avastin), and traditional chemotherapy in patients with non-small cell lung cancer (NSCLC) appeared to be safe and effective in a phase II clinical trial. Patients with advanced non-squamous NSCLC received Erbitux and Avastin in addition to carboplatin (Paraplatin) and paclitaxel (Taxol/Abraxane) as first-line treatment, followed by maintenance treatment with Erbitux and Avastin. Tumors shrank in 56% of patients and stopped growing in an additional 21%. Serious side effects were relatively rare; the rate was comparable to that of either Erbitux or Avastin alone. Both Erbitux and Avastin have shown efficacy in NSCLC by themselves, but may be more effective when given together. An ongoing phase III clinical trial will further investigate this drug combination.


Alimta Offers Only Limited Advantage in Lung Cancer Study

The recent PointBreak clinical trial compared two treatment regimens for non-squamous non-small cell lung cancer (NSCLC). Previously untreated patients with advanced non-squamous NSCLC received initial treatment with carboplatin (Paraplatin), bevacizumab (Avastin), and either pemetrexed (Alimta) or paclitaxel (Taxol/Abraxane). The Alimta-treated group was then given maintenance treatment with Alimta and Avastin, while the other patients received Avastin only. Alimta treatment was associated with slightly longer times until the cancer progressed again (average 6.0 months, compared to 5.6 in the Alimta-free regimen). However, overall survival did not differ between the groups. The two regimens differed in what specific side effect were most common, but had similar overall toxicities and were generally tolerable.