Neoadjuvant Nivolumab Appears Safe and Feasible in Lung Cancer

Excerpt:

“Neoadjuvant immunotherapy with the programmed cell death protein 1 (PD-1) inhibitor nivolumab (Opdivo) is safe and feasible in early-stage non–small cell lung cancer (NSCLC). The results come from the first report of PD-1 blockade prior to surgery in this tumor, according to Patrick Forde, MD, of The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, who reported these findings at the 2016 European Society for Medical Oncology (ESMO) Congress.

” ‘Thirty-nine percent of patients with early-stage NSCLC treated with two doses of nivolumab had major pathologic responses associated with immune cell infiltration of tumor,’ Dr. Forde reported. ‘One hypothesis is that having tumor in situ when you give anti–PD-1—having more antigen present—may be better than giving it in the adjuvant setting, where only micrometastases may be present.’ ”

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Nivolumab Combos Explored in First-Line NSCLC Trial

Excerpt:

“Although nivolumab (Opdivo) has demonstrated a clear survival advantage compared with chemotherapy in patients with progressive non–small cell lung cancer (NSCLC) who express PD-L1 in their tumor cells, the same cannot be said for those who are PD-L1–negative.

“As a result, researchers are seeking to elicit antitumor activity in a broader range of patients, notably through a multiarm trial evaluating the PD-1 inhibitor along with combinatorial approaches.

“CheckMate-227 (NCT02477826) is a phase III, open-label, randomized trial for patients with chemotherapy-naïve stage IV or recurrent NSCLC. The trial will enroll patients into separate groups according to PD-L1 expression status (≥1% or <1%).”

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Incidence of PD-1 Inhibitor–Related Pneumonitis Highest in NSCLC, Renal Cell Carcinoma

Excerpt:

“PD-1 inhibitor–related pneumonitis occurred most frequently among patients with non–small cell lung cancer or renal cell carcinoma, according to results of a meta-analysis.

“The incidence of this adverse event also appeared greater during treatment with combination therapy.

“PD-1 inhibitors — including FDA–approved nivolumab (Opdivo, Bristol-Myers Squibb) and pembrolizumab (Keytruda, Merck) — are associated with unique toxicities known as immune-related adverse events. Pneumonitis is one such adverse event that, although rare, can be serious and life threatening.”

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Melanoma: New Drugs and New Challenges (Part 2 of 2)


Editor’s note: This is part 2 of a 2-part post on the latest research in melanoma. To learn about research into drug combinations for melanoma that may work better than single drugs, check out Melanoma: New Drugs and New Challenges (Part 1 of 2).

As always, the more new treatments become available in melanoma, the more new challenges arise. With eight new drugs approved for melanoma in the last five years, oncologists may sometimes face the difficult choice of what drugs to choose for a patient’s first-line treatment. Immune checkpoint drugs sometimes cause serious side effects, but progress is being made on how to treat these and also how to treat patients with pre-existing autoimmune conditions. New approaches are needed in efforts to prevent recurrence of melanomas diagnosed at earlier stages of disease progression. These and other challenges are discussed below. Continue reading…


Novel Combination Study Planned for SCLC

Excerpt:

“A phase I/II study will explore the delta-like protein 3 (DLL3)-targeted antibody-drug conjugate rovalpituzumab tesirine (Rova-T) with the PD-1 inhibitor nivolumab (Opdivo) alone or in combination with the CTLA-4 inhibitor ipilimumab (Yervoy) for patients with relapsed extensive-stage small cell lung cancer (SCLC).

“AbbVie, the developer of rovalpituzumab tesirine, and Bristol-Myers Squibb, the company marketing nivolumab and ipilimumab announced the phase I/II study in a joint press release. As single-agents, rovalpituzumab tesirine and nivolumab have each demonstrated promising early findings for patients with SCLC. Additionally, nivolumab plus ipilimumab sparked promising response rates and overall survival (OS) findings. Data for the 3 agents were recently presented at the 2016 ASCO Annual Meeting.”

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Pfizer Presents Data from Phase 1b Trial Investigating Utomilumab (a 4-1BB agonist) in Combination with a Checkpoint Inhibitor

Excerpt:

“Pfizer Inc. PFE -0.26% today announced results from a Phase 1b trial of Pfizer’s investigational immunotherapy agent utomilumab (the proposed non-proprietary name for PF-05082566), a 4-1BB (also called CD137) agonist, in combination with pembrolizumab, a PD-1 inhibitor, in patients with advanced solid tumors. This is the first reported study of a 4-1BB agonist combined with a checkpoint inhibitor. Encouraging safety data from the study were shared today as an oral presentation at the 52 [nd] Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.

“ ‘While these are early data, the combination of utomilumab with pembrolizumab demonstrates an encouraging safety profile and an early indication of potential anti-tumor activity across solid tumors,’ said Anthony W. Tolcher, M.D., director of clinical research at South Texas Accelerated Research Therapeutics (START) San Antonio. ‘We believe these results warrant further investigation to confirm whether combining utomilumab with a checkpoint inhibitor may amplify anti-tumor responses.’ ”

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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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