Making sense of 1st-line immunotherapy in non-small cell lung cancer (NSCLC)
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THIS POST CONTAINS 'OFF-LABEL' INFORMATION ON INDICATIONS NOT YET APPROVED BY THE US FDA


Medical Writer: Stijn van den Borne, MSc
Last updated on 26 March 2018

Brief Communication

Making Sense of Immunotherapy for Non-Small Cell Lung Cancer (NSCLC)

Rapid development and fast-tracked approvals of immune-checkpoint inhibitors have led to the first registration in non-small cell lung cancer (NSCLC) in 2015. Just over two years later, immunotherapies start to dominate the frontline treatment of NSCLC. This expansion of therapeutic options will soon reflect in dramatic changes to the treatment guidelines, where immunotherapies are expected to complement the chemotherapeutic options. A brief communication of the relevant immuno-oncology data in NSCLC.

Making sense of immunotherapy in NSCLC

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Pembrolizumab immunotherapy in the 1st-line NSCLC

In the open-label Phase II KEYNOTE-021 study, the addition of pembrolizumab to carboplatin and pemetrexed in patients with non-squamous NSCLC (N=123) improved the overall response rate (ORR) to 55% from 29% with the doublet alone (P=0.0032). An improvement regardless of PD-L1 expression. The median progression-free survival (PFS) was 13.0 months with the addition of pembrolizumab vs 8.9 months for the pemetrexed/carboplatin doublet (HR=0.53, P=0.0205, 95% CI, 0.31-0.91). Patients in the pembrolizumab arm continued to receive the immunotherapy up to 24 months. After a median 10.6 months follow-up, 88% of patients in the experimental-arm remained alive and progression-free compared to 78% of patients receiving the doublet.

The multi-centre, double-blind, Phase III KEYNOTE-189 trial confirmed the early results of the KEYNOTE-021 study. In the KEYNOTE-189 study, 616 EGFR- or ALK-negative non-squamous NSCLC patients were randomised 2:1 to receive frontline pembrolizumab or placebo in combination with pemetrexed and a platinum salt. The co-primary endpoints of improved overall survival (OS) and PFS were met and published in the New England Journal of Medicine in April 2018.

Single-agent pembrolizumab

At a median follow-up of 25.2 months in the open-label KEYNOTE-024 study, pembrolizumab more than doubled median OS compared to platinum-based chemotherapy in 154 NSCLC patients with a PD-L1 expression ≥50% and negative EGFR- or ALK-status. Single-agent pembrolizumab led to a 30.2 months OS vs 14.2 months with chemotherapy (HR=0.63, P=0.002; 95% CI, 0.47-0.86) despite the crossover of 82 patients from the chemotherapy-arm to the pembrolizumab-arm. The 24-month OS-rate favoured pembrolizumab vs platinum doublet: 51.5% vs 34.5% respectively and the ORR was 45.5% in the pembrolizumab-arm compared to 29.8% in the chemotherapy-arm.

Common pembrolizumab-related side effects.

Durvalumab for maintenance after frontline chemoradiotherapy in NSCLC

The phase III PACIFIC trial (N=709) randomised patients 2:1 to either receive durvalumab or placebo after chemoradiotherapy. Durvalumab-maintenance therapy was associated with improved median PFS, 16.8 months in the durvalumab-group vs 5.6 months in the placebo group (HR=0.52, P<0.0001; 95% CI, 0.42-0.65). The 12-month and 18-month PFS-rates both favoured the immunotherapy: 55.9% (durvalumab) vs 35.3% (placebo) and 44.2% (durvalumab) vs 27.0% (placebo) respectively, and was irrespective of PD-L1 expression before chemoradiotherapy. Durvalumab treatment was associated with a higher ORR of 28.4% vs 16.0% with placebo. Patients with a response to the immune-checkpoint inhibitor had durable, ongoing responses of 72.8% at both 12 and 18 months. In the placebo-arm, the 12- and 18-month ORRs were 56.1% and 46.8%, respectively.

Common durvalumab-related side effects.


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Nivolumab plus ipilimumab immunotherapy in front-line NSCLC

Preliminary results of the Phase III CheckMate 227 show that the combination of nivolumab and ipilimumab improves PFS when compared with chemotherapy in treatment-naïve patients with high mutation burden (high-TMB) NSCLC. The co-primary PFS endpoints was met and published in the New England Journal of Medicine in April 2018.

Common nivolumab and ipilimumab-related side effects.

Atezolizumab immunotherapy in the 1st-line treatment of NSCLC

In the multicenter, open-label Phase II IMpower131, the addition of atezolizumab to 4 or 6 cycles of carboplatin and nab-paclitaxel in the 1st-line delayed progression or death compared with chemotherapy alone in patients with advanced squamous non–small cell lung cancer (NSCLC). The co-primary endpoints were PFS and overall survival OS and the latter was not improved. The results have not yet been published.

The Phase III IMpower150 trial previously showed that the addition of atezolizumab to bevacizumab, carboplatin, and paclitaxel delayed progression or death by 38% in patients with advanced non-squamous NSCLC. The median PFS improved to 8.3 months compared with 6.8 months for bevacizumab and chemotherapy alone (HR=0.62, P<0.0001; 95% CI=0.52-0.74). The 12-month PFS-rate was 37% after addition of atezolizumab vs 18% for bevacizumab plus chemotherapy alone. The preliminary OS improved to 19.2 months vs 14.4 months respectively (HR=0.775, P=0.0262; 95% CI=0.619-0.970).

Common atezolizumab-related side effects.

REFERENCES

1. Prescribing information pembrolizumab (Keytruda®), revised: 11/2017
2. Langer, CJ et al. Lancet Oncol 2016;17(11):1497-1508
3. Merck Press Release KEYNOTE-189, accessed 26 March 2018
4. Prescribing information durvalumab (Imfinzi®), revised: 02/2018
5. Antonia SJ et al. N Engl J Med. 2017;377(20):1919-29
6. BMS Press Release CheckMate-227, accessed 26 March 2018
7. Prescribing information nivolumab (Opdivo®), revised: 02/2018
8. Roche Press Release IMpower-131, accessed 26 March 2018
9. Reck M et al. Ann Oncol 2017;28(S11):xi31
10. Prescribing information atezolizumab (Tecentriq®), revised: 04/2017

Disclaimer

This article is not medical advice. Patients should seek personal assessment by a licenced specialist. Physicians are recommended to read the full publication(s) as cited in the article before making medical decisions. This article does not supersede nor replace the published article(s).

© Copyright 2018 MediPaper Medical Communications Ltd. - Making sense of immunotherapy for non-small cell lung cancer (NSCLC)

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/wp-content/uploads/2016/10/ESMO-2016-Breast-Cancer-Palbociclib-Ribociclib-Abemaciclib-data-MediPaper-Medical-Writer-e1478671413852.jpg 1000 1500 Stijn van den Borne, MSc /wp-content/uploads/2018/04/MediPR-MediPaper-Medical-Communications-Ltd-Healthcare-Writers-Medical-Writers-Medical-Writer-Agency-Hong-Kong-Medical-Writing-Services-Solutions-Quote-醫學寫作-香港-醫學作家香港-medical-PR-medical-public-relations-e1523021883812.png Stijn van den Borne, MSc2016-11-09 16:00:442018-02-09 14:07:59ESMO16 Breast Cancer: Palbociclib, Ribociclib and Abemaciclib Data
PD-L1 Biomarker for Response DAKO 22C3 - MediPaper Medical Communications

PD-L1 Biomarker: a Comparison of ASCO2016 PD-1 and PD-L1 Data

/wp-content/uploads/2016/08/PD-L1-Biomarker-for-Response-DAKO-22C3-MediPaper-Medical-Communications.png 1000 1500 Stijn van den Borne, MSc /wp-content/uploads/2018/04/MediPR-MediPaper-Medical-Communications-Ltd-Healthcare-Writers-Medical-Writers-Medical-Writer-Agency-Hong-Kong-Medical-Writing-Services-Solutions-Quote-醫學寫作-香港-醫學作家香港-medical-PR-medical-public-relations-e1523021883812.png Stijn van den Borne, MSc2016-10-26 14:00:352018-04-21 23:25:28PD-L1 Biomarker: a Comparison of ASCO2016 PD-1 and PD-L1 Data
Biomarkers Ipilimumab Treatment MediPaper Medical Communications

Novel Biomarker for Ipilimumab Treatment may aid Future Patient Selection in Several Malignancies

/wp-content/uploads/2016/10/Biomarkers-Ipilimumab-Treatment-MediPaper-Medical-Communications.jpg 1000 1500 Stijn van den Borne, MSc /wp-content/uploads/2018/04/MediPR-MediPaper-Medical-Communications-Ltd-Healthcare-Writers-Medical-Writers-Medical-Writer-Agency-Hong-Kong-Medical-Writing-Services-Solutions-Quote-醫學寫作-香港-醫學作家香港-medical-PR-medical-public-relations-e1523021883812.png Stijn van den Borne, MSc2016-10-24 10:12:072018-02-09 14:07:59Novel Biomarker for Ipilimumab Treatment may aid Future Patient Selection in Several Malignancies
ESMO 2016 ipilimumab data medipaper medical communications

ESMO16 Ipilimumab data - Download the PPT

/wp-content/uploads/2016/09/ESMO-2016-ipilimumab-data-medipaper.jpg 667 1000 Stijn van den Borne, MSc /wp-content/uploads/2018/04/MediPR-MediPaper-Medical-Communications-Ltd-Healthcare-Writers-Medical-Writers-Medical-Writer-Agency-Hong-Kong-Medical-Writing-Services-Solutions-Quote-醫學寫作-香港-醫學作家香港-medical-PR-medical-public-relations-e1523021883812.png Stijn van den Borne, MSc2016-10-11 11:10:102018-04-21 23:13:39ESMO16 Ipilimumab data - Download the PPT
ESMO 2016 pembrolizumab data medipaper medical communications

ESMO16 Pembrolizumab data - Download the PPT

/wp-content/uploads/2016/09/ESMO-2016-pembrolizumab-data-medipaper.jpg 667 1000 Stijn van den Borne, MSc /wp-content/uploads/2018/04/MediPR-MediPaper-Medical-Communications-Ltd-Healthcare-Writers-Medical-Writers-Medical-Writer-Agency-Hong-Kong-Medical-Writing-Services-Solutions-Quote-醫學寫作-香港-醫學作家香港-medical-PR-medical-public-relations-e1523021883812.png Stijn van den Borne, MSc2016-10-10 21:08:122018-04-21 23:10:22ESMO16 Pembrolizumab data - Download the PPT
ESMO 2016 durvalumab avelumab tremelimumab data medipaper medical communications

ESMO16 Durvalumab, Avelumab, Tremelimumab Data - Download the PPT

/wp-content/uploads/2016/10/ESMO-2016-durvalumab-avelumab-tremelimumab-data-medipaper.jpg 667 1000 Stijn van den Borne, MSc /wp-content/uploads/2018/04/MediPR-MediPaper-Medical-Communications-Ltd-Healthcare-Writers-Medical-Writers-Medical-Writer-Agency-Hong-Kong-Medical-Writing-Services-Solutions-Quote-醫學寫作-香港-醫學作家香港-medical-PR-medical-public-relations-e1523021883812.png Stijn van den Borne, MSc2016-10-10 10:30:512018-02-09 14:07:58ESMO16 Durvalumab, Avelumab, Tremelimumab Data - Download the PPT
ESMO 2016 atezolizumab data medipaper medical communications

ESMO16 Atezolizumab data - Download the PPT

/wp-content/uploads/2016/09/ESMO-2016-atezolizumab-data-medipaper.jpg 665 1000 Stijn van den Borne, MSc /wp-content/uploads/2018/04/MediPR-MediPaper-Medical-Communications-Ltd-Healthcare-Writers-Medical-Writers-Medical-Writer-Agency-Hong-Kong-Medical-Writing-Services-Solutions-Quote-醫學寫作-香港-醫學作家香港-medical-PR-medical-public-relations-e1523021883812.png Stijn van den Borne, MSc2016-10-09 17:50:232018-02-09 14:07:58ESMO16 Atezolizumab data - Download the PPT
ESMO 2016 nivolumab data medipaper medical communications

ESMO16 Nivolumab data - Download the PPT

/wp-content/uploads/2016/09/ESMO-2016-nivolumab-data-medipaper.jpg 667 1000 Stijn van den Borne, MSc /wp-content/uploads/2018/04/MediPR-MediPaper-Medical-Communications-Ltd-Healthcare-Writers-Medical-Writers-Medical-Writer-Agency-Hong-Kong-Medical-Writing-Services-Solutions-Quote-醫學寫作-香港-醫學作家香港-medical-PR-medical-public-relations-e1523021883812.png Stijn van den Borne, MSc2016-10-09 16:30:582018-04-21 23:16:08ESMO16 Nivolumab data - Download the PPT
cancer awareness improves outcome medipaper medical communications

Cancer symptom awareness linked to survival

/wp-content/uploads/2016/09/cancer-awareness-improves-outcome-medipaper-medical-communications.jpg 1000 1500 Stijn van den Borne, MSc /wp-content/uploads/2018/04/MediPR-MediPaper-Medical-Communications-Ltd-Healthcare-Writers-Medical-Writers-Medical-Writer-Agency-Hong-Kong-Medical-Writing-Services-Solutions-Quote-醫學寫作-香港-醫學作家香港-medical-PR-medical-public-relations-e1523021883812.png Stijn van den Borne, MSc2016-09-30 21:33:432018-02-09 13:51:10Cancer symptom awareness linked to survival
2016 ASCO ovarian cancer guidelines neo-adjuvant chemotherapy medipaper medical communications

ASCO Guideline NeoAdjuvant Chemotherapy for Ovarian Cancer Updated

/wp-content/uploads/2016/09/2016-asco-ovarian-cancer-guidelines-neo-adjuvant-chemotherapy-medipaper-medical-communications-e1478394814429.png 1000 1500 Stijn van den Borne, MSc /wp-content/uploads/2018/04/MediPR-MediPaper-Medical-Communications-Ltd-Healthcare-Writers-Medical-Writers-Medical-Writer-Agency-Hong-Kong-Medical-Writing-Services-Solutions-Quote-醫學寫作-香港-醫學作家香港-medical-PR-medical-public-relations-e1523021883812.png Stijn van den Borne, MSc2016-09-27 21:53:422018-02-09 14:07:58ASCO Guideline NeoAdjuvant Chemotherapy for Ovarian Cancer Updated
IMM-101 plus gemcitabine-medipaper medical communications BW

IMM101 plus Gemcitabine Hopeful in Metastatic Pancreatic Cancer

/wp-content/uploads/2016/09/IMM-101-plus-gemcitabine-medipaper-medical-communications_medical_writer_hong_kong.jpg 844 1500 Stijn van den Borne, MSc /wp-content/uploads/2018/04/MediPR-MediPaper-Medical-Communications-Ltd-Healthcare-Writers-Medical-Writers-Medical-Writer-Agency-Hong-Kong-Medical-Writing-Services-Solutions-Quote-醫學寫作-香港-醫學作家香港-medical-PR-medical-public-relations-e1523021883812.png Stijn van den Borne, MSc2016-09-25 00:19:582018-02-09 13:51:09IMM101 plus Gemcitabine Hopeful in Metastatic Pancreatic Cancer
palbociclib-first-in-class

Palbociclib (Ibrance®): First in Class CDK4/6 Inhibitor

/wp-content/uploads/2016/04/palbociclib-first-in-class.jpg 662 1095 Stijn van den Borne, MSc /wp-content/uploads/2018/04/MediPR-MediPaper-Medical-Communications-Ltd-Healthcare-Writers-Medical-Writers-Medical-Writer-Agency-Hong-Kong-Medical-Writing-Services-Solutions-Quote-醫學寫作-香港-醫學作家香港-medical-PR-medical-public-relations-e1523021883812.png Stijn van den Borne, MSc2016-09-17 00:46:162018-02-09 14:07:58Palbociclib (Ibrance®): First in Class CDK4/6 Inhibitor
Ki67 breast cancer medical writer epotomics

Ki67 in Breast Cancer: an overview

/wp-content/uploads/2016/04/Ki67-breast-cancer-medical-writer-epotomics-com.png 998 1500 Stijn van den Borne, MSc /wp-content/uploads/2018/04/MediPR-MediPaper-Medical-Communications-Ltd-Healthcare-Writers-Medical-Writers-Medical-Writer-Agency-Hong-Kong-Medical-Writing-Services-Solutions-Quote-醫學寫作-香港-醫學作家香港-medical-PR-medical-public-relations-e1523021883812.png Stijn van den Borne, MSc2016-09-06 00:07:072018-02-09 13:51:09Ki67 in Breast Cancer: an overview
ASCO 2016 ribociclib & abemaciclib Data - MediPaper Medical Communications

ASCO16 Ribociclib & Abemaciclib Data

/wp-content/uploads/2016/06/ribociclib-abemaciclib-ASCO2016-Data-MediPaper-Medical-Communications.jpg 1033 1500 Stijn van den Borne, MSc /wp-content/uploads/2018/04/MediPR-MediPaper-Medical-Communications-Ltd-Healthcare-Writers-Medical-Writers-Medical-Writer-Agency-Hong-Kong-Medical-Writing-Services-Solutions-Quote-醫學寫作-香港-醫學作家香港-medical-PR-medical-public-relations-e1523021883812.png Stijn van den Borne, MSc2016-06-05 23:30:482018-02-09 14:07:58ASCO16 Ribociclib & Abemaciclib Data
ASCO 2016 Palbociclib Data MediPaper Medical Communications

ASCO16 palbociclib (Ibrance©) Data

/wp-content/uploads/2016/06/ASCO-2016-Palbociclib-Data-MediPaper-Medical-Communications.jpg 1000 1500 Stijn van den Borne, MSc /wp-content/uploads/2018/04/MediPR-MediPaper-Medical-Communications-Ltd-Healthcare-Writers-Medical-Writers-Medical-Writer-Agency-Hong-Kong-Medical-Writing-Services-Solutions-Quote-醫學寫作-香港-醫學作家香港-medical-PR-medical-public-relations-e1523021883812.png Stijn van den Borne, MSc2016-06-04 22:51:302018-02-09 14:07:58ASCO16 palbociclib (Ibrance©) Data
ASCO 2016 Avelumab Durvalumab and Tremelimumab Data - MediPaper Medical Communications

ASCO16 Avelumab, Durvalumab, and Tremelimumab

/wp-content/uploads/2016/06/ASCO-2016-Azelumab-Durvalumab-and-Tremelimumab-Data.jpg 938 1500 Stijn van den Borne, MSc /wp-content/uploads/2018/04/MediPR-MediPaper-Medical-Communications-Ltd-Healthcare-Writers-Medical-Writers-Medical-Writer-Agency-Hong-Kong-Medical-Writing-Services-Solutions-Quote-醫學寫作-香港-醫學作家香港-medical-PR-medical-public-relations-e1523021883812.png Stijn van den Borne, MSc2016-06-03 11:57:432018-02-09 14:07:58ASCO16 Avelumab, Durvalumab, and Tremelimumab
asco 2016 atezolizumab data

ASCO16 Atezolizumab (Tecentriq©) Data

/wp-content/uploads/2016/06/asco-2016-atezolizumab-data.jpg 1200 1800 Stijn van den Borne, MSc /wp-content/uploads/2018/04/MediPR-MediPaper-Medical-Communications-Ltd-Healthcare-Writers-Medical-Writers-Medical-Writer-Agency-Hong-Kong-Medical-Writing-Services-Solutions-Quote-醫學寫作-香港-醫學作家香港-medical-PR-medical-public-relations-e1523021883812.png Stijn van den Borne, MSc2016-06-02 15:15:132018-02-28 21:44:52ASCO16 Atezolizumab (Tecentriq©) Data
ASCO2016 ipilimumab data - MediPaper Medical Communications

ASCO16 Ipilimumab (Yervoy©) Data

/wp-content/uploads/2016/05/ASCO2016-ipilimumab-data-MediPaper-Medical-Communications.jpg 938 1500 Stijn van den Borne, MSc /wp-content/uploads/2018/04/MediPR-MediPaper-Medical-Communications-Ltd-Healthcare-Writers-Medical-Writers-Medical-Writer-Agency-Hong-Kong-Medical-Writing-Services-Solutions-Quote-醫學寫作-香港-醫學作家香港-medical-PR-medical-public-relations-e1523021883812.png Stijn van den Borne, MSc2016-05-31 13:05:442018-04-23 08:42:10ASCO16 Ipilimumab (Yervoy©) Data
asco 2016 nivolumab medipaper medical communications

ASCO16 Nivolumab (Opdivo©) Data

/wp-content/uploads/2016/05/asco-2016-nivolumab.jpg 1000 1500 Stijn van den Borne, MSc /wp-content/uploads/2018/04/MediPR-MediPaper-Medical-Communications-Ltd-Healthcare-Writers-Medical-Writers-Medical-Writer-Agency-Hong-Kong-Medical-Writing-Services-Solutions-Quote-醫學寫作-香港-醫學作家香港-medical-PR-medical-public-relations-e1523021883812.png Stijn van den Borne, MSc2016-05-29 00:44:422018-04-23 08:41:40ASCO16 Nivolumab (Opdivo©) Data
asco 2016 pembrolizumab medipaper medical communications

ASCO16 Pembrolizumab (Keytruda©) Data

/wp-content/uploads/2016/05/asco-2016-pembrolizumab.jpg 851 1500 Stijn van den Borne, MSc /wp-content/uploads/2018/04/MediPR-MediPaper-Medical-Communications-Ltd-Healthcare-Writers-Medical-Writers-Medical-Writer-Agency-Hong-Kong-Medical-Writing-Services-Solutions-Quote-醫學寫作-香港-醫學作家香港-medical-PR-medical-public-relations-e1523021883812.png Stijn van den Borne, MSc2016-05-29 00:23:322018-04-23 08:41:55ASCO16 Pembrolizumab (Keytruda©) Data
asco 2016 immune checkpoint inhibitors

ACC2016: 8½ Important Cardiology Lessons Learned

/wp-content/uploads/2016/04/acc2016-chicago-take-away-messages.jpg 1672 2508 Stijn van den Borne, MSc /wp-content/uploads/2018/04/MediPR-MediPaper-Medical-Communications-Ltd-Healthcare-Writers-Medical-Writers-Medical-Writer-Agency-Hong-Kong-Medical-Writing-Services-Solutions-Quote-醫學寫作-香港-醫學作家香港-medical-PR-medical-public-relations-e1523021883812.png Stijn van den Borne, MSc2016-04-04 22:11:202017-11-25 14:09:33ACC2016: 8½ Important Cardiology Lessons Learned
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  1. Approved Immune-Checkpoint Inhibitors and Immunotherapies per 5-APR-2018 says:
    April 23, 2018 at 9:23 am

    […] non-small cell lung cancer (NSCLC) with PD-L1 TPS (tumour proportion score) ≥1% […]

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  2. First-line Nivolumab-Ipilimumab in TMB-high NSCLC | MediPaper says:
    April 21, 2018 at 9:58 am

    […] programmed death 1 (PD-1) inhibitor nivolumab with chemotherapy (Figure 1). Eligible patients had Stage IV or recurrent NSCLC and not received prior systemic treatment. Participants were stratified as squamous NSCLC and non-squamous NSCLC.Subjects with insufficient […]

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  3. Combination Pembrolizumab Chemotherapy in NSCLC active | MediPaper says:
    April 19, 2018 at 12:59 pm

    […] Phase III KEYNOTE-189 study recruited 616 treatment-naïve advanced and metastatic nonsquamous NSCLC patients to receive frontline pembrolizumab or placebo (2:1) in combination with pemetrexed and […]

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