WCLC 2019: Updates from the Pembrolizumab Clinical Development Program

Senior woman with lung cancer during medical visit
Senior woman with lung cancer during medical visit

Lung cancer, which forms in the tissues of the lungs, in most cases within cells lining the air passages, is the leading cause of cancer death worldwide. In 2019, an estimated 228,150 new cases of lung cancer (116,440 in men and 111,710 in women) will be diagnosed and about 142,670 will die from the disease (76,650 in men and 66,020 in women).[1]

Each year, more people die of lung cancer than die of colon and breast cancers combined. The two main types of lung cancer are non-small cell and small cell.

Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for about 85% of all cases. Small cell lung cancer (SCLC) accounts for about 10 to 15% of all lung cancers. According to recent 2019 data from the American Cancer Society, the five-year survival rates for patients diagnosed in the United States with any stage of NSCLC or SCLC are estimated to be 23% and 6%, respectively.[1]

During the upcoming 20th World Conference on Lung Cancer (WCLC 2019) of the International Association for the Study of Lung Cancer (IASLC), which will be held September 7 – 10, 2019 in Barcelona, Spain, expect exciting news about the development of novel treatments as well as updates of existing treatments.

The World Conference on Lung Cancer has become the premier platform not only for the presentation of new science, but also for unique networking opportunities.*

During the upcoming lung cancer conference Merck, known as MSD outside the United States and Canada, is expected to present new data from the company’s leading clinical development program in lung cancer.

More than 30 abstracts evaluating pembrolizumab (Keytruda®), Merck’s anti-PD-1 therapy, in combination with other cancer therapies and as monotherapy, will be presented.

Keynote trial program
Key data to be presented in non-small cell lung cancer (NSCLC) include new pooled findings from three trials – KEYNOTE-189, KEYNOTE-407 and KEYNOTE-021 (cohort G) – evaluating pembrolizumab in combination with chemotherapy among a subgroup of patients whose tumors do not express PD-L1. Three-year overall survival (OS) data with pembrolizumab monotherapy from KEYNOTE-024 will also be presented.

Jonathan Cheng, MD. Photo Courtesy: Merck/MSD. “….we look forward to presenting new and updated data that further reinforce the overall survival benefit of pembrolizumab….”

“Our robust lung cancer clinical development program continues to demonstrate that pembrolizumab provides a foundation for the treatment of non-small cell lung cancer,” Jonathan Cheng, MD, vice president, oncology clinical research, Merck Research Laboratories.

“At this year’s World Conference on Lung Cancer, we look forward to presenting new and updated data that further reinforce the overall survival benefit of pembrolizumab, in combination with chemotherapy or as monotherapy, in appropriate patients with advanced non-small cell lung cancer,” Cheng added.

Key oral data presentations during the World Conference on Lung Cancer related to pembrolizumab include:

AbstractTitleDate/Location
#MA25.01First presentation of pooled data from a subgroup of patients whose tumors do not express PD-L1 from the randomized KEYNOTE-189, KEYNOTE-407 and KEYNOTE-021 (cohort G) studies evaluating KEYTRUDA in combination with chemotherapy as first-line treatment in patients with advanced nonsquamous and squamous NSCLCMini oral session on Tuesday, Sept. 10, 2:30-2:37 p.m. CEST.
#OA14.01Three-year OS data from the pivotal Phase 3 KEYNOTE-024 study evaluating KEYTRUDA monotherapy as first-line treatment in patients with advanced NSCLC whose tumors express PD-L1 (tumor proportion score [TPS] ≥50%)Oral session on Tuesday, Sept. 10, 11:30-11:40 a.m. CEST
#MA11.02First presentation of data from a cohort of Chinese patients enrolled in the pivotal Phase 3 KEYNOTE-042 study evaluating KEYTRUDA monotherapy as first-line treatment in patients with advanced NSCLC whose tumors express PD-L1 (TPS ≥1%)Mini oral session on Monday, Sept. 9, 2:05-2:10 p.m. CEST.
#OA04.06First presentation of tissue tumor mutational burden (tTMB) data from the pivotal Phase 3 KEYNOTE-189 study evaluating KEYTRUDA in combination with pemetrexed (ALIMTA®) and platinum chemotherapy as first-line treatment in patients with metastatic nonsquamous NSCLCOral session on Sunday, Sept. 8, 4:10-4:20 p.m. CEST and
#OA04.05First presentation of tTMB data from the Phase 1/2 KEYNOTE-021 study evaluating KEYTRUDA in combination with platinum chemotherapy as first-line treatment in patients with metastatic nonsquamous NSCLC**Oral session on Sunday, Sept. 8, 4:00-4:10 p.m. CEST
#MA03.06Efficacy Results of Selective AXL Inhibitor Bemcentinib with Pembrolizumab Following Chemotherapy in Patients with NSCLC.

Presented by: E. Felip.

Mini Oral Session:  Sunday, Sept. 8, 11:05-11:10 a.m. CEST.

Location: Colorado Springs (1994).

#MA14.07Phase I Expansion Cohort of Ramucirumab Plus Pembrolizumab in Advanced Treatment-Naïve Non-Small Cell Lung Cancer (JVDF).

Presented by: R. Herbst

Mini Oral Session:  . Monday, Sept. 9, 4:25-4:30 p.m. CEST.

Location: Hilton Head (1978).

#MA19.03Differences in Symptom Burden Between Responsive and Progressive Disease in Advanced Non-Small Cell Lung Cancer (aNSCLC).

Presented by: G. Simon

Mini Oral Session:  . Tuesday, Sept. 10, 11:40-11:45 a.m. CEST.

Location: Interlaken (1988).

#P1.01-72A Phase II Study of Selective AXL Inhibitor Bemcentinib and Pembrolizumab in Patients with NSCLC Refractory to Anti-PD(L)1.

Presented by: M. Krebs.

Poster Presentation: Sunday, Sept. 8, 9:45 a.m. CEST.

Location: Exhibit Hall.

#P1.01-73An Explorative Analysis of Pemetrexed +/- Pembrolizumab Maintenance from KEYNOTE-189 Versus PARAMOUNT, PRONOUNCE, and JVBL.

Presented by: E. Garon.

Poster Presentation: Sunday, Sept. 8, 9:45 a.m. CEST.

Location: Exhibit Hall.

#P1.01-107KEYNOTE-495/KeyImPaCT: Phase 2 Biomarker-Directed Study of Pembrolizumab-Based Therapy for Non–Small Cell Lung Cancer.

Presented by: M. Gutierrez

Poster Presentation: Sunday, Sept. 8, 9:45 a.m. CEST. Location: Exhibit Hall.
#P1.01-112Phase 3, Randomized, Double-Blind Trial of First-Line Pembrolizumab With or Without Lenvatinib in Metastatic NSCLC: LEAP-007

Presented by: T. Mekhail

Poster Presentatin: Sunday, Sept. 8, 9:45 a.m. CEST.

Location: Exhibit Hall.

#P1.16-15Rates of Systemic Anticancer Therapy (SACT) for Advanced Non-Small Cell Lung Cancer (aNSCLC) in the US, 2011–2018.

Presented by: V. Velcheti

Poster Presentation: Sunday, Sept. 8, 9:45 a.m. CEST.

Location: Exhibit Hall.

#P1.16-31Body Mass Index Relating to Patient-Reported Symptoms in First-Line Treatment of Metastatic Non-Small Cell Lung Cancer.

Presented by: G. Simon

Poster Presentation: Sunday, Sept. 8, 9:45 a.m. CEST. Location: Exhibit Hall.
#P1.16-42Real-World Trends in Systemic Anticancer Therapy (SACT) for Squamous Advanced NSCLC (aNSCLC) in the US, 2011–2018.

Presented by: V. Velcheti

Poster Presentation: Sunday, Sept. 8, 9:45 a.m. CEST.

Location: Exhibit Hall

#P2.16-17Real-World Trends in Systemic Therapy for Nonsquamous EGFR/ALK-Negative Advanced NSCLC (aNSCLC) in the US, 2011–2018.

Presented by: V. Velcheti

Poster Presentation: Monday, Sept. 9, 10:15 a.m. CEST.

Location: Exhibit Hall.

#P2.16-41Pembrolizumab for Previously Treated, PD-L1–Expressing Advanced NSCLC: Real-World Time on Treatment and Overall Survival.

Presented by: V. Velcheti

Poster Presentation: Monday, Sept. 9, 10:15 a.m. CEST.

Location: Exhibit Hall.

#P2.01-54Real-World PD-L1 Testing Patterns for Patients with Advanced Non-Small Cell Lung Cancer in Greece.

Presented by: K. Syrigos.

Poster Presentation: Monday, Sept. 9, 10:15 a.m. CEST.

Location: Exhibit Hall.

#P2.01-12A Phase I/II Trial of IO102 and Pembrolizumab with/without Chemotherapy as First-line Treatment of Metastatic NSCLC.

Presented by: M. Provencio

Poster Presentation: Monday, Sept. 9, 10:15 a.m. CEST.

Location: Exhibit Hall.

Note:
* During the meeting, the team of The Onco’Zine Brief will conduct interviews with Key Opinion Leaders for broadcasts later in September.
** The KEYNOTE-021 (cohort G) and KEYNOTE-189 studies were conducted in collaboration with Eli Lilly and Company, the makers of pemetrexed (Alimta®).

Clinical Trials
A Study of Pembrolizumab (MK-3475) in Combination With Chemotherapy or Immunotherapy in Participants With Non-small Cell Lung Cancer (MK-3475-021/KEYNOTE-021) – NCT02039674
Study of Pembrolizumab (MK-3475) Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (MK-3475-024/KEYNOTE-024) – NCT02142738
Study of Pembrolizumab (MK-3475) Versus Platinum-Based Chemotherapy for Participants With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Advanced or Metastatic Non-Small Cell Lung Cancer (MK-3475-042/KEYNOTE-042) – NCT02220894
Study of Pemetrexed+Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in Participants With First Line Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-3475-189/KEYNOTE-189) – NCT02578680
A Study of Carboplatin-Paclitaxel/Nab-Paclitaxel Chemotherapy With or Without Pembrolizumab (MK-3475) in Adults With First Line Metastatic Squamous Non-small Cell Lung Cancer (MK-3475-407/KEYNOTE-407) – NCT02775435
A Study of Biomarker-Directed, Pembrolizumab (MK-3475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (MK-3475-495/KEYNOTE-495) – NCT03516981
IO102 With Pembrolizumab, With or Without Chemotherapy, as First-line Treatment of Metastatic NSCLC – NCT03562871
Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) in Adults With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Treatment-naïve Non-small Cell Lung Cancer (NSCLC)(MK-7902-007/E7080-G000-314/LEAP-007) – NCT03829332

Reference
[1] Key Statistics for Lung Cancer. How common is lung cancer? American Cancer Society. Online.Last accessed August 22, 2019.