Pembrolizumab Long-Term Survival Rate Could Reach 25% in NSCLC

Excerpt:

“Treatment with pembrolizumab (Keytruda) could elicit long-term survival (LTS) rates of 21% to 25% for previously-treated patients with PD-L1–positive non–small cell lung cancer (NSCLC) compared with 3% to 4% for docetaxel, according to a statistical analysis of findings from the KEYNOTE-010 and -001 trials presented at the 2017 ASCO-SITC Symposium.

“Findings from the analysis shed light on the number of patients with advanced NSCLC expected to benefit for up to 70 months from pembrolizumab. According to survival statistics from the SEER database for 2006 to 2012, the 5-year survival rate was 4.3% for those with lung or bronchus cancer with distant metastases.”

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Dual Biomarker Signature Holds Predictive Promise for Response to Anti-PD-L1 Therapy in NSCLC

Excerpt:

“Recent research suggests that the presence of PD-L1–positive and CD8+ cells may be useful for predicting responses in patients with non-small cell lung cancer (NSCLC) who have been treated with durvalumab (MEDI4736).

“Sonja Althammer, PhD, presented research on the association between improved survival rates to treatment with durvalumab and high CD8+ and PD-L1+ cell densities during a late-breaking abstract session at the Society for Immunotherapy of Cancer (SITC) 21st Annual Meeting & Associated Programs.”

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Nivolumab/Ipilimumab Frontline Response Nears 60% in PD-L1+ NSCLC

Excerpt:

“Upfront treatment with the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) demonstrated an objective response rate (ORR) of 57% in patients with PD-L1-positive advanced non–small cell lung cancer (NSCLC), according to updated pooled findings from the phase Ib CheckMate-012 study presented at the 2016 ASCO Annual Meeting.

“In the 3-arm study, patients received nivolumab alone or in combination with ipilimumab every 6 weeks (Q6W) or every 12 weeks (Q12W). Across the full population, which was not selected based on PD-L1 expression, single-agent nivolumab had an ORR of 23%. In the combination arms, the ORRs were 47% and 39%, in the Q12W and Q6W arms, respectively.”

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Atezolizumab Continues To Show Potential in NSCLC

“With atezolizumab (MPDL3280A) showing great potential as a treatment for patients with non–small cell lung cancer (NSCLC) in two particlar studies, we sat down with Chandra P. Belani, MD, to talk more about the treatment.

“The PD-L1 inhibitor received a breakthrough therapy designation from the FDA based on early-stage studies as a potential treatment for patients with PD-L1–positive NSCLC, post-progression on prior therapies such as chemotherapy and targeted therapies. Belani, Miriam Beckner Distinguished Professor of Medicine, Penn State Milton S. Hershey Medical Center, deputy director, Penn State Hershey Cancer Institute, said in an interview with Targeted Oncology, that the acitivity the treatment shows is impressive.”


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.”


To PD-L1 or Not to PD-L1: That Is the Question


These days, it seems that I write mostly about immune checkpoint blockade drugs, or some other new immunotherapy treatment for cancer. This post is no different—it covers PD-L1, a protein that is at the center of clinical decisions for selecting patients who are likely to benefit from treatment with an anti-PD-1 or anti-PD-L1 drug. Continue reading…


Immunotherapy Combo Cuts Melanoma Death Risk

“An immunotherapy combination for untreated melanoma reduced the risk of death or progression by more than half as compared with a drug currently used as a standard of care, a large randomized trial showed.

“Patients treated with nivolumab (Opdivo) and ipilimumab (Yervoy) had a median progression-free survival (PFS) of 11.5 months compared with 2.9 months for ipilimumab alone and 6.9 months with nivolumab monotherapy. Median PFS with the combination and with nivolumab alone increased to 14 months — more than four times greater than the PFS of patients who received only ipilimumab — among patients whose tumors tested positive for programmed death receptor ligand 1 (PD-L1), the target of nivolumab.

“The PFS improvement came at a price of increased toxicity, as grade 3/4 adverse events occurred twice as often with the combination as with ipilimumab monotherapy, but even patients who discontinued treatment because of side effects did better with the combination, as reported here at the American Society of Clinical Oncology meeting.”


Tests for New Cancer Drugs Not Reliable Enough, Doctors Say

“Drugmakers including Bristol-Myers Squibb Co and Merck & Co are testing which patients will most benefit from new cancer treatments based on a protein found in their tumors, but that guide, known as a biomarker, may be too unreliable, researchers and health experts said.

“Bristol’s Opdivo and Merck’s Keytruda are both therapies designed to block a protein known as Programmed Death receptor (PD-1) that tumors use to evade the body’s natural defenses. Competitors Roche Holding, AstraZeneca and Pfizer also have similar drugs in an earlier stage of development. The drugmakers are conducting clinical trials that test patient tumors for a related protein called PD-L1.

“The new drugs are mainly aimed at patients with so-called solid tumors suffering from diseases including lung cancer and liver cancer. Lung cancer, the most common type, claims 1.8 million new cases each year worldwide. Sales of drugs to block PD-1 could reach $33 billion a year by 2022, according to Morningstar.”


AstraZeneca and MedImmune Present Positive Immuno-Oncology Combination Data at ASCO 2015

“AstraZeneca AZN, -0.75% and MedImmune, AstraZeneca’s global biologics research and development arm, today presented encouraging results from their novel combination-focused immuno-oncology portfolio at the American Society of Clinical Oncology (ASCO) Annual Meeting 2015.

“Overall, data indicated clinical activity with manageable safety profiles for the anti-programmed cell death ligand 1 (PD-L1) monoclonal antibody MEDI4736, both as monotherapy and in combination with other immuno-oncology and small molecule therapies across different tumor types and tumor biology.

“MEDI4736 and tremelimumab combination shows clinical activity and tolerability in both PD-L1 positive and PD-L1 negative advanced non-small cell lung cancer (NSCLC) patients; dose confirmed for future studies

“Results from the combination study of MEDI4736 and tremelimumab, a cytotoxic T-lymphocyte-associated protein-4 (CTLA-4) monoclonal antibody, in the treatment of advanced NSCLC, demonstrated clinical activity in heavily-pretreated patients with a manageable safety profile, establishing appropriate doses to move forward into Phase III combination trials.”