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Disease Analysis: Gastric Cancer

  • ID: 5141806
  • Report
  • March 2021
  • Region: Global
  • 80 pages
  • Datamonitor Healthcare
Disease Overview

Stomach or gastric cancer (GC) refers to any cancer arising in the lining of the stomach. The vast majority (95%) of these cancers are adenocarcinomas, and can be further grouped by anatomic origin. The clearest etiological distinction exists between adenocarcinomas of the gastric cardia (the anterior edge of the stomach surrounding the entry point of the esophagus), and those arising in the other anatomical subsites of the stomach - the fundus, body, pylorus, and the antrum. In most cases, gastric adenocarcinomas will begin in the muscularis mucosae and submucosa, then invading deeper lamina of the gastric wall.

Latest Key Takeaways

The publisher estimates that in 2018, there were 1.0 million incident cases of gastric cancer worldwide in adults aged 20 years and older, and forecasts that number to increase to 1.1 million incident cases by 2027.

The majority of gastric cancer diagnoses (66.1%) worldwide are in males, ranging from 54.3% to 68.3% across regions.

A major etiological factor of gastric cancer, especially in poorer countries, is Helicobacter pylori infection of the stomach wall. With H. pylori infections falling worldwide, the bacterium’s decreasing prevalence may have an effect on the future number of case diagnoses.

Approximately 75% of all gastric cancer diagnoses are in Asia. Particularly high incidence rates in East Asia make Japan a very large market for gastric cancer medications.

Early-stage gastric cancer is often asymptomatic, meaning that most diagnoses are only made in advanced disease. An exception to this trend is Japan, where proactive screening often discovers tumors in a locoregional setting.

Due to the lack of curative treatments in advanced disease, the prognosis of gastric cancer is rather poor in most countries, with five-year survival rates standing at 20% worldwide. Even in Japan, where screening often catches early-stage tumors, relatively high rates of recurrence keep this rate at 71.5%.

HER2, PD-1, and receptor tyrosine kinases (RTKs) are the most common molecular targets for both branded and pipeline drugs. However, the treatment landscape remains dominated by non-targeted chemotherapies, with most targeted agents confined to one or two treatment settings, where they are typically administered alongside chemotherapy.

Despite a failed expansion to front-line therapy, the vascular endothelial growth factor receptor (VEGFR) antagonist Cyramza is arguably the most successful targeted therapy in gastric cancer, having become the standard of care in second-line disease.

Immune checkpoint inhibitors (ICIs) - specifically the PD-1 antagonists Opdivo and Keytruda - are in development in multiple treatment settings, but remain largely confined to heavily pretreated (third-line or later) patients in Japan and the US, respectively. Keytruda is also approved in second-line disease, but only for microsatellite instability-high (MSI-H) tumors, which account for a small minority of the total population.

No targeted therapies exist for locoregional disease, although Opdivo and Keytruda are in ongoing Phase III trials for this setting.

Trastuzumab biosimilars are now available, leading to a sharp decline in the market share of Herceptin.

Set to succeed Herceptin, next-generation HER2 antibodies Margenza and Enhertu (an antibody-drug conjugate) are now expanding into gastric cancer, the latter of which has recently launched in Japan and the US.

No targeted treatments are available for front-line HER2-negative gastric cancer (approximately 80% of cases), making it one of the largest areas of unmet need in the disease space. As a result, multiple drugs - including Opdivo, Yervoy, Keytruda, tislelizumab, bemarituzumab, and zolbetuximab - are now in late-stage development for this setting.

Though most pipeline drugs in late-stage development involve the classic molecular targets of PD-1/PD-L1 and RTKs, the PARP inhibitor pamiparib is in development for second-line disease, and zolbetuximab is exploring the entirely novel target of claudin-18. Additionally, the pipeline ICI tebotelimab is a dual-affinity re-targeting antibody (DART) that is bispecific to LAG3 as well as PD-1.

Underwhelming benefits seen in multiple Phase III trials of PD-1 inhibitor monotherapies (including in KEYNOTE-062 and KEYNOTE-061 for Keytruda, ATTRACTION-2 for Opdivo, and JAVELIN Gastric 100 for Bavencio) have stymied the launch of single-agent checkpoint inhibitors in earlier lines of therapy.

Given the inconclusive results of KEYNOTE-062, Keytruda’s approval in first-line HER2-negative disease will likely hinge on KEYNOTE-859, which is evaluating Keytruda combined with chemotherapy and is slated for completion in 2023. As such, the Opdivo-Yervoy dual blockade combination of CheckMate 649 is positioned to reach the front-line gastric cancer market first, having recently demonstrated a robust clinical benefit over the current standard of care of chemotherapy.

CheckMate 649 also includes an Opdivo-chemotherapy combination arm, which in 2020 became the first targeted therapy to produce a durable benefit in HER2-negative first-line disease. Though the regimen is not yet approved, it is now recommended by the NCCN as an off-label therapy for highly immunogenic (CPS ≥5) PD-L1+ tumors.
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OVERVIEW
  • Latest key takeaways
DISEASE BACKGROUND
  • Definition
  • Risk factors
  • Symptoms
  • Patient segmentation
  • Diagnosis
  • Prognosis
TREATMENT
  • Treatment techniques
  • Preferred systemic therapies for resectable locoregional disease
  • Preferred systemic therapies for advanced, unresectable or recurrent disease
  • Approved branded drugs
EPIDEMIOLOGY
  • Incidence methodology
MARKETED DRUGS

PIPELINE DRUGS

KEY REGULATORY EVENTS
  • Opdivo Seeks New Gastric Cancer Uses
  • FDA Approval Opens Up Gastric Cancer To Daiichi Sankyo/AZ’s Enhertu
  • AZ Looks To Convert Recent BTDs To Approvals For Enhertu, Tagrisso
'Sakigake' Treatment Gives Enhertu Rapid Japan OK For Gastric Cancer
  • Henlius’ Trastuzumab Approved In China
  • Enhertu Breaks Through In HER2-Positive Gastric Cancer
  • Pfizer Launches Biosimilar Trastuzumab In US
PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS
  • TRIGR, Elpiscience Partner On Cancer Immunotherapy In China
  • Prestige Lines Up Another Biosimilar Partner With Teva Subsidiary
  • Pfizer Bets $480m On CStone And Surging China Immuno-Oncology Market
  • Twice As Nice: Seattle Genetics, Merck & Co. Partner On Two Cancer Drugs
  • Henlius Partners With Mabxience On Trastuzumab
  • Deals Shaping The Medical Industry, February 2020
  • CLINICAL TRIAL LANDSCAPE
  • Sponsors by status
  • Sponsors by phase
  • Recent events
DRUG ASSESSMENT MODEL

MARKET DYNAMICS

FUTURE TRENDS
  • Brands scramble to launch in front-line HER2-negative advanced gastric cancer
  • New treatment options for HER2-positive patients on the horizon
  • Cyramza is likely to remain a standard of care in second-line disease
  • Declining prevalence of H. pylori may slow gastric cancer incidence growth
CONSENSUS FORECASTS

RECENT EVENTS AND ANALYST OPINION
  • Bemarituzumab for Gastric Cancer (November 10, 2020)
  • Opdivo for Gastric Cancer (September 21, 2020)
  • Bavituximab for Gastric Cancer (September 18, 2020)
  • Opdivo for Gastric Cancer (August 11, 2020)
  • ALX148 for Gastric Cancer (May 29, 2020)
  • Enhertu for Gastric Cancer (May 29, 2020)
  • Enhertu for Gastric Cancer (January 27, 2020)
  • Motixafortide for Gastric Cancer (January 24, 2020)
  • Bavencio for Gastric Cancer (November 8, 2019)
  • Margenza for Gastric Cancer (September 30, 2019)
KEY UPCOMING EVENTS

KEY OPINION LEADER INSIGHTS

UNMET NEEDS

BIBLIOGRAPHY
  • Prescription information
APPENDIX

LIST OF FIGURES
Figure 1: AJCC prognostic groups for gastric cancer (clinical staging)
Figure 2: Definitions of the diagnostic criteria for primary tumor (T), regional lymph nodes (N), and distant metastasis (M) in gastric cancer
Figure 3: Trends in incident cases of gastric cancer, 2018–27
Figure 4: Overview of pipeline drugs for gastric cancer in the US
Figure 5: Pipeline drugs for gastric cancer, by company
Figure 6: Pipeline drugs for gastric cancer, by drug type
Figure 7: Pipeline drugs for gastric cancer, by classification
Figure 8: Probability of success in the gastric cancer pipeline
Figure 9: Clinical trials in gastric cancer
Figure 10: Top 10 drugs for clinical trials in gastric cancer
Figure 11: Top 10 companies for clinical trials in gastric cancer
Figure 12: Trial locations in gastric cancer
Figure 13: Gastric cancer trials status
Figure 14: Gastric cancer trials sponsors, by phase
Figure 15: The publisher’s drug assessment summary for gastric cancer
Figure 16: Market dynamics in gastric cancer
Figure 17: Future trends in gastric cancer
Figure 18: Bemarituzumab for Gastric Cancer (November 10, 2020): Phase II - FIGHT (w/mFOLFOX6)
Figure 19: Opdivo for Gastric Cancer (September 21, 2020): Phase III - CheckMate-649 (w/Ipilimumab)
Figure 20: Bavituximab for Gastric Cancer (September 18, 2020): Phase II - w/Pembrolizumab
Figure 21: Opdivo for Gastric Cancer (August 11, 2020): Phase III - CheckMate-649
Figure 22: Enhertu for Gastric Cancer (May 29, 2020): Phase II - DESTINY-Gastric01 (Japan/Korea)
Figure 23: Enhertu for Gastric Cancer (January 27, 2020): Phase II - DESTINY-Gastric01 (Japan/Korea)
Figure 24: Motixafortide for Gastric Cancer (January 24, 2020): Phase Ib/II - G/GEJ UMBRELLA
Figure 25: Bavencio for Gastric Cancer (November 8, 2019): Phase III - JAVELIN Gastric 100
Figure 26: Margenza for Gastric Cancer (September 30, 2019): Phase Ib/II - w/Pembrolizumab
Figure 27: Key upcoming events in gastric cancer
Figure 28: Unmet needs in gastric cancer

LIST OF TABLES
Table 1: Recommended therapies for locally advanced, resectable gastric adenocarcinoma
Table 2: Recommended front-line systemic therapies for recurrent/metastatic and unresectable gastric cancer
Table 3: Recommended subsequent-line systemic therapies for recurrent/metastatic and unresectable gastric cancer
Table 4: Approved branded drugs for gastric cancer
Table 5: Incident cases of gastric cancer, 2018–27
Table 6: Incident cases of gastric cancer, by gender, 2018
Table 7: Marketed drugs for gastric cancer
Table 8: Pipeline drugs for gastric cancer in the US
Table 9: Historical global sales, by drug ($m), 2015–19
Table 10: Forecasted global sales, by drug ($m), 2021–25
Table 11: Bemarituzumab for Gastric Cancer (November 10, 2020)
Table 12: Opdivo for Gastric Cancer (September 21, 2020)
Table 13: Bavituximab for Gastric Cancer (September 18, 2020)
Table 14: Opdivo for Gastric Cancer (August 11, 2020)
Table 15: ALX148 for Gastric Cancer (May 29, 2020)
Table 16: Enhertu for Gastric Cancer (May 29, 2020)
Table 17: Enhertu for Gastric Cancer (January 27, 2020)
Table 18: Motixafortide for Gastric Cancer (January 24, 2020)
Table 19: Bavencio for Gastric Cancer (November 8, 2019)
Table 20: Margenza for Gastric Cancer (September 30, 2019)
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