Atezolizumab/Nab-Paclitaxel Approved by the FDA for PD-L1+ TNBC

Excerpt:

“An accelerated approval has been granted by the FDA for the combination of atezolizumab (Tecentriq) and nab-paclitaxel (Abraxane) as a frontline treatment for patients with unresectable locally advanced or metastatic PD-L1–positive triple-negative breast cancer (TNBC).

“The approval is based on the phase III IMpassion130 trial, in which the addition of the PD-L1 inhibitor atezolizumab to nab-paclitaxel reduced the risk of progression or death by 40% compared with nab-paclitaxel alone in this patient population.”

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Pembrolizumab Alone or With Chemotherapy for PD-L1–Positive NSCLC?

Excerpt:

“Researchers found that in patients with non–small-cell lung cancer (NSCLC) and a Tumor Proportion Score (TPS) ≥ 50, pembrolizumab plus chemotherapy failed to improve overall survival (OS) or progression-free survival (PFS) compared with pembrolizumab alone.

“Results from the study were presented in a poster presentation at the International Association for the Study of Lung Cancer (IASLC) 19th World Conference on Lung Cancer, held September 23–26 in Toronto.”

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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.”