Expert Examines Immunotherapy Potential in Small Cell Lung Cancer

Excerpt:

“Several ongoing clinical trials are examining the efficacy and safety of immunotherapy agents in patients with small cell lung cancer (SCLC), explains David P. Carbone, MD, PhD.

“Two early phase studies have already shown encouraging results. In the phase I/II CheckMate-032 trial, pretreated patients with SCLC received monotherapy with the PD-1 inhibitor nivolumab (Opdivo) or the combination of nivolumab plus the CTLA-4 inhibitor ipilimumab (Yervoy). Data showed that the median progression-free survival (PFS) was 3.35 months with the combination and 1.38 months with nivolumab alone. Median OS was 7.75 months with the combination and 3.55 months with single-agent therapy. The objective response rate (ORR) with the combination was 31.1%.

“In the phase Ib KEYNOTE-028 trial, the PD-1 inhibitor pembrolizumab (Keytruda) had an ORR of 29.2% (95% CI, 12.6-51.1) in patients with SCLC who had prior chemotherapy.”

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EU Expands Nivolumab Approval for Lung and Kidney Cancer

Excerpt:

“The European Commission has approved new indications for the immunotherapy nivolumab (Opdivo, Bristol-Myers Squibb), expanding its use in the treatment of non-small-cell lung cancer (NSCLC), and adding the indication of renal cell carcinoma (RCC).

“The drug is already approved in Europe for use in previously treated patients with metastatic squamous NSCLC. Now the indication has been expanded to include non-squamous NSCLC, which represents 85% of the cases of lung cancer, and monotherapy in locally advanced or metastatic disease.

“Nivolumab is the only PD-1 inhibitor that has been approved for a broad range of patients with previously treated metastatic NSCLC, regardless of PD-L1 expression, and nivolumab is the only approved PD-1 inhibitor to demonstrate a better overall survival rate than docetaxel in previously treated metastatic NSCLC, the manufacturer pointed out in a press release.”

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Advaxis Combination Trial with Merck Completes First Two Dose-Escalation Cohorts

Excerpt:

Advaxis, Inc. (ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, and Merck & Co., Inc. (MRK), today announced that they have completed the first two dose-escalation cohorts and launched the third dose-escalation cohort in their KEYNOTE-046 clinical trial. The Phase 1/2 study is evaluating the combination of ADXS-PSA (ADXS31-142) and KEYTRUDA® (pembrolizumab), the first anti-PD-1 (programmed death receptor-1) therapy approved in the United States, in patients with previously treated, metastatic castration-resistant prostate cancer (mCRPC).

“The KEYNOTE-046 trial is the first-in-human study of Advaxis’ Lm immunotherapy candidate for prostate cancer. It is the second study initiated to evaluate the use of KEYTRUDA in the treatment of advanced prostate cancer.”

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The Growing Arsenal of Immunotherapy Drugs for Melanoma


Large numbers of immune cells (T cells in particular) are frequently found within or adjacent to melanoma tumors, indicating that the tumors attract the attention—if not the action—of the immune system. True to its reputation as one of the most ‘immunogenic‘ cancers, melanoma now has more U.S. Food and Drug Administration (FDA)-approved immunotherapy (immune system-targeting) drugs than any other cancer type. As a consequence, metastatic melanoma is no longer the universally fatal disease it was even just 3 or 4 years ago. Continue reading…


FDA Approves Two New Indications for Pembrolizumab in Advanced Melanoma

“The FDA has expanded the approval for single-agent pembrolizumab (Keytruda) to include the frontline treatment of patients with advanced melanoma regardless of BRAF status, based on a substantial improvement in progression-free and overall survival compared with ipilimumab (Yervoy) in the phase III KEYNOTE-006 trial.

“In the study, which compared 2 pembrolizumab regimens with ipilimumab, the PD-1 inhibitor reduced the risk of disease progression by >40% and the risk of death by >30%.

“ ‘As recently as five years ago, there were few treatment options for patients suffering from advanced melanoma,’ Roger M. Perlmutter, MD, PhD, president, Merck Research Laboratories, the developer of the PD-1 inhibitor, said in a statement. ‘Today’s news is another exciting milestone for Keytruda and for patients with this disease.’ “


New Promising Drugs for Small Cell Lung Cancer


Any type of advanced lung cancer is bad news, but a diagnosis of small cell lung cancer (SCLC) is a particularly grim one to receive. About 30 years have passed since any new treatments for SCLC were developed, and patients’ responses to standard chemotherapy with etoposide and cisplatin are short-lived. Hopefully, this will change soon.

We begin this post with the immune checkpoint inhibitors, a type of immunotherapy that is explored in seemingly every type of cancer, including SCLC. Reports from two clinical trials of these drugs were recently made available at two meetings on lung cancer treatment. Continue reading…


New Long-Term Data on Opdivo and the Opdivo + Yervoy Regimen Shows Survival Benefit Across Lines of Therapy in Advanced Melanoma

“Bristol-Myers Squibb Company (NYSE:BMY) today announced new long-term data of Opdivo in treatment-naïve BRAF wild-type advanced melanoma from CheckMate -066. In the trial, Opdivo continued to demonstrate superior overall survival versus dacarbazine with 57.7% of patients alive at two years compared to 26.7% of patients treated with dacarbazine. The safety profile of Opdivo was consistent with prior studies. The two-year survival and safety data from CheckMate -066 represent the longest follow-up from a randomized study of any PD-1 immune checkpoint inhibitor in the first-line setting of advanced melanoma. These data will be presented as a late-breaking presentation at the Society for Melanoma Research (SMR) 2015 International Congress in San Francisco, CA from November 18 to 21.”


FDA Approves Pembrolizumab for PD-L1-Positive Lung Cancer

“The FDA granted an accelerated approval to pembrolizumab (Keytruda) as a treatment for patients with pretreated advanced non­–small cell lung cancer (NSCLC) across all histologies whose tumors express PD-L1. The PD-1 inhibitor was approved along with a companion diagnostic, the PD-L1 IHC 22C3 pharmDx test, and is indicated for patients who progressed on or after platinum-containing chemotherapy or EGFR-or ALK-targeted agents in patients harboring those mutations.

“The approval was based on data from the phase I KEYNOTE-001 trial, in which the overall response rate (ORR) with the drug was 41% among a subgroup of 61 patients with pretreated PD-L1­–positive advanced NSCLC as determined by the 22C3 pharmDx diagnostic test. Response duration ranged from 2.1 to 9.1 months. A survival improvement has yet to be demonstrated in a clinical trial, and the accelerated approval is contingent upon the eventual outcomes of confirmatory studies.”


Madison Vaccines Announces Patient Dosing Underway in Clinical Trial Pairing Its Lead Prostate Cancer Vaccine, MVI-816, with PD1 Inhibitor Pembrolizumab

“Madison Vaccines Incorporated (MVI) today announced dosing has begun in a combination trial for MVI-816 (pTVG-HP), its lead prostate cancer vaccine, paired with pembrolizumab (Keytruda®), a PD-1 inhibitor, also called a checkpoint inhibitor. A PD-1 inhibitor works by exposing cancer cells to attack by the immune system by preventing the cancer cells from blocking an effective immune response. MVI-816, already in a Phase 2 clinical trial as monotherapy, has been shown to induce persistent T-cell responses in prostate cancer patients. The combination trial will test the hypothesis that both treatments work together synergistically. The first-of-its kind combination to reach this stage will be tested in men with metastatic, castrate-resistant prostate cancer, and will be conducted at the University of Wisconsin – Madison, Carbone Cancer Center under the direction of Douglas McNeel, MD, PhD, a leading prostate cancer researcher at the university.”