Pembrolizumab in metastatic NSCLC: Now added benefit for subpopulations

September 20, 2019

In early July, the German Institute for Quality and Efficiency in Health Care (IQWiG) conducted two early benefit assessments to investigate whether certain drug combinations with pembrolizumab have advantages in comparison with the respective appropriate comparator therapy for patients with metastatic squamous or non-squamous non-small cell lung cancer (NSCLC). Due to a contradictory presentation of the operationalization of the key outcome "overall survival" in the drug manufacturer's dossiers, the presented data were not interpretable, however.

The manufacturer resolved the contradictions in the subsequent commenting procedure: It had conducted correct analyses on overall survival, but had provided a wrong presentation in the dossiers. IQWiG was now able to include these analyses in two addenda to the original assessments: An added benefit was shown for specific subpopulations.

Gene expression influences the results

In both commissions, the Federal Joint Committee (G-BA) had distinguished between two groups of patients, i.e. those whose tumours express the T-cell receptor ligand PD-L1 with over 50 per cent, and those with a PD-L1 expression of under 50 per cent. In one of the commissions, the data additionally suggested a modification of the results by sex.

Overall, there is now proof of major added benefit for women and an indication of minor added benefit for men in the first-line treatment of non-squamous NSCLC without EGFR or ALK-positive tumour mutations with PD-L1 expression below 50 per cent. If PD-L1 expression is above 50 per cent, there is a hint of a major added benefit for women, whereas for men, there is a hint of lesser benefit in comparison with the appropriate comparator therapy.

In first-line treatment of squamous NSCLC, however, sex does not influence the results of treatment with pembrolizumab. There is an indication of major added benefit in PD-L1 expression below 50 per cent. An added benefit is not proven for men or women with PD-L1 expression above 50 per cent.

G-BA decides on the extent of added benefit

The dossier assessments are part of the early benefit assessment according to the Act on the Reform of the Market for Medicinal Products (AMNOG) supervised by the G-BA. After publication of the manufacturer dossiers and the IQWiG dossier assessments, the manufacturer submitted additional information in the commenting procedure. The G-BA subsequently commissioned IQWiG to assess this information. IQWiG now presents this assessment in the form of two addenda. The G-BA makes final decisions on the extent of added benefit.

The English translation of the addenda will be published soon. If you would like to be informed when these documents are available, please send an e-mail to info@iqwig.de.
-end-


Institute for Quality and Efficiency in Health Care

Related Pembrolizumab Articles from Brightsurf:

Personalized cancer vaccine clinical trial to expand following promising early results
A University of Arizona Health Sciences clinical trial to study safety and effectiveness of a personalized cancer vaccine combined with immunotherapy drug Pembrolizumab will expand after promising preliminary data was presented at the Society for the Immunotherapy of Cancer's annual meeting.

Singapore researchers discover genetic link to predict positive response to immunotherapy in patient
Findings offer cost and clinical benefits for patients with natural-killer T-cell lymphoma undergoing novel anti PD-1 therapy.

COMBAT study preliminary results show response of 32% in treatment of pancreatic tumors
Working with an international team of researchers, HonorHealth Research Institute and the Translational Genomics Research Institute (TGen), an affiliate of City of Hope, were instrumental in one of the first clinical trials showing how pancreatic cancer patients can benefit from immunotherapy, according to a four-year study published in a premier scientific journal, Nature Medicine.

A blood test could predict who benefits from immunotherapy
A test which detects changing levels of tumour fragments in the blood may be an easy, non-invasive and quick way to predict who will benefit from immunotherapy, a treatment option for advanced cancers.

Investigational breast cancer vaccine plus immune therapy work well in tandem
A vaccine for HER2-positive breast cancers that is being tested in a clinical trial at Duke Cancer Institute is part of an effective, two-drug strategy for enlisting the immune system to fight tumors, according to a Duke-led study in Clinical Cancer Research, a journal of the American Association for Cancer Research.

Immunotherapy for bowel cancer could change clinical practice
A large international trial involving UCL and University College London Hospitals NHS Foundation Trust (UCLH) has found that pembrolizumab, a form of immunotherapy, more than doubled the 'progression free survival' time of patients with a specific subtype of advanced bowel cancer, when compared with chemotherapy.

Interleukin-12 electroporation may sensitize 'cold' melanomas to immunotherapies
Combining intratumoral electroporation of interleukin-12 (IL-12) DNA (tavokinogene telseplasmid, or TAVO) with the immune checkpoint inhibitor pembrolizumab (Keytruda) led to clinical responses in patients with immunologically quiescent advanced melanoma, according to results from a phase II trial.

Immunotherapy treatment after chemotherapy significantly slows metastatic bladder cancer
Using immunotherapy immediately after chemotherapy treatment in patients with metastatic bladder cancer significantly slowed the progression of the cancer, according to results of a clinical trial led by Mount Sinai researchers published in the Journal of Clinical Oncology in April, 2020.

Pembrolizumab shows promise for some advanced, hard-to-treat rare cancers
Pembrolizumab shows promise for some advanced, hard-to-treat rare cancers. Open-label Phase II study at MD Anderson reports on four cancer types.

New research shows which ovarian cancer patients won't benefit from immune-PARP combo
In patients with advanced ovarian cancer, a combination of drugs known as immune checkpoint inhibitors and PARP inhibitors can produce powerful remissions, clinical trials have shown, but up until now investigators haven't been able to predict which patients won't benefit from the treatment and should explore other options.

Read More: Pembrolizumab News and Pembrolizumab Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.