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Non-Small Cell Lung Cancer (NSCLC) Disease Forecast and Market Analysis to 2035

  • ID: 4238712
  • Drug Pipelines
  • July 2020
  • Region: Global
  • 165 Pages
  • Datamonitor Healthcare
Disease Overview

Lung cancer is a disease in which the cells in lung tissue grow uncontrollably. More than 80% of lung cancers are non-small cell lung cancer (NSCLC), with the exact proportion depending on the country in question. The main types of NSCLC are squamous cell carcinoma, adenocarcinoma, and large cell carcinoma. NSCLC presents significant public health problems for nearly every country, largely due to the fact that diagnosis generally happens in the advanced stages, and there is a high death rate associated with the disease.

Latest Key Takeaways

The publisher estimates that in 2018, there were 1.8 million incident cases of non-small cell lung cancer (NSCLC) worldwide, and expects that number to increase to 1.9 million incident cases by 2027. The majority of NSCLC diagnoses (65.4%) worldwide are in males, ranging from 52.9% to 72.1% across regions.

In the last three years, the number of therapies targeting specific sensitizing mutations in metastatic NSCLC has drastically increased, permanently altering the treatment landscape. Many of the new drugs have shown dramatically increased response rates over the previous standard-of-care therapies. However, given the relatively small percentage of metastatic NSCLC patients presenting with each oncogenic driver, competition is fierce and first-to-market advantage is critical.

Programmed death-1 (PD-1)/programmed death-ligand 1 (PD-L1)-targeted monoclonal antibodies for NSCLC are forecast to remain the best-selling class of drugs for this indication. Keytruda was the first PD-1/PD-L1 inhibitor to gain regulatory approval for first-line NSCLC patients without an oncogenic driver, and has risen to dominance in this market as label expansions have broadened its target patient population and as late-phase trials have revealed consistently positive data. Furthermore, the commercial potential of this class of drugs will increase over the forecast period as the use of checkpoint inhibitors will likely soon extend beyond the metastatic patient population. Label expansions into the earlier treatment settings may provide an opportunity for the other checkpoint inhibitors to differentiate themselves from Keytruda and carve out a niche in this lucrative market.

PD-L1 inhibitor Imfinzi’s approval for sequential therapy of locally advanced patients following chemoradiation minimizes direct competition with established immunotherapies, and has allowed the drug to secure a modest market share.

Third-generation EGFR inhibitor Tagrisso is now the first-line standard-of-care treatment for NSCLC patients whose tumors harbor activating EGFR mutations (exon 19 deletion or L858R point mutation). Despite competition from Tarceva, Iressa, Gilotrif, Vizimpro, and Alunbrig, Tagrisso will continue to dominate the EGFR inhibitor market due to continued uptake and an expected label expansion in the adjuvant setting.

The EGFR inhibitors mobocertinib and poziotinib are currently in late-stage development for metastatic NSCLC patients whose tumors harbor an exon 20 insertion mutation in EGFR, a population of patients where currently approved therapies are not effective. Mobocertinib is predicted to be the first therapy to market and will likely dominate in this patient population as poziotinib recently failed to demonstrate efficacy in the first-line setting. However, the relative rarity of this mutation will limit the drug’s commercial potential.

Alecensa has become the new first-line standard of care for ALK rearrangement-positive NSCLC. The Phase III ALEX study demonstrated superior progression-free survival when treated with Alecensa compared with previous standard of care Xalkori. Alecensa will likely remain the class leader even though it will face competition in the first-line setting from other ALK inhibitors such as Zykadia, Alunbrig, and Lorbrena. Dual ALK/ROS1 inhibitor Lorbrena was recently approved in the second-line setting but has experienced only modest uptake thus far. Additionally, Lorbrena will face competition from the other approved ALK inhibitors and pipeline drug ensartinib.

The ALK inhibitors Rozlytrek and Xalkori are both approved for the treatment of metastatic NSCLC patients whose tumors have a ROS1 rearrangement or fusion. Rozlytrek is also approved as a monotherapy for patients with NTRK+ gene fusions. The combined data from Rozlytrek’s development program compare favorably to the data for Xalkori, particularly in patients with CNS metastases at baseline. ROS1 gene rearrangements are present in 1–2% of NSCLC patients, while NTRK fusions are present in approximately 0.2% of cases.

The combination of BRAF inhibitor Tafinlar and MEK inhibitor Mekinist has become the standard of care for advanced or metastatic NSCLC with BRAF V600E mutations. However, only 1–2% of NSCLC patients have a BRAF V600E mutation, which limits the combination’s commercial potential.

Two MET inhibitors have been approved for NSCLC patients with a MET exon 14 skipping mutation: Tabrecta in the US and Japan, and Tepmetko in Japan. Both drugs are also in development for MET-amplified NSCLC and for patients with EGFR-mutated, c-MET-amplified NSCLC who have progressed after EGFR inhibitor treatment. Potential label expansions into these treatment settings represent a noteworthy market opportunity. Approximately 1–4% of NSCLC patients have a MET exon 14 skipping mutation.

Retevmo is the first drug approved for the treatment of patients with RET fusion-positive NSCLC. In the pivotal Phase I/II trial, Retevmo demonstrated efficacy in RET fusion-positive patients and in a subgroup of patients with brain metastases. The confirmatory Phase III LIBRETTO-431 trial is ongoing, and approvals in both Europe and Japan are expected based on the Phase I/II data. However, Retevmo will soon face competition from RET inhibitor pralsetinib, although this pipeline drug will likely struggle to gain market share.

As therapies targeting specific oncogenic drivers have established themselves in metastatic NSCLC, attention has shifted toward mutations that do not yet have targeted therapies. One notable pipeline example is KRAS inhibitor sotorasib. Sotorasib is being investigated as a second-line or later treatment for patients with KRAS G12C-mutant NSCLC, a patient population that was previously thought to be undruggable. This is a significant market opportunity given that approximately 13% of NSCLC patients have KRAS p.G12C mutations.

As checkpoint inhibitor regimens dominate in the first-line setting for patients without sensitizing mutations, effective treatments for the post-immunotherapy setting remain the largest unmet need within the indication. Treatment for these patients is largely palliative, and patients currently have very limited treatment options. A number of therapies, including Cabometyx, Lenvima, sitravatinib, and SAR408701, are currently in development for this treatment setting.

The overall likelihood of approval of a Phase I NSCLC asset is 6.8%, and the average probability a drug advances from Phase III is 34.7%. NSCLC drugs, on average, take 8.9 years from Phase I to approval, compared to 9.3 years in the overall oncology space.

Key upcoming catalysts for 2020 include topline results for the Phase III JAVELIN Lung 100 study of Bavencio, the Phase III IMpower010 study of Tecentriq, and the Phase III CheckMate-816 study of Opdivo and Yervoy.
Note: Product cover images may vary from those shown
Overview
  • Latest key takeaways
Disease Background
  • Definition
  • Risk factors
  • Symptoms
  • Screening
  • Diagnosis
  • Prognosis
  • Patient segmentation
Treatment
  • Early-stage NSCLC (Stage I–II; all subtypes)
  • Advanced NSCLC (Stage IIIa–IIIc; all subtypes)
  • Metastatic NSCLC – molecular profiling
  • Metastatic NSCLC: EGFR+
  • Metastatic NSCLC: EGFR+, second line
  • Metastatic NSCLC: ALK+
  • Metastatic NSCLC: ROS1+
  • Metastatic NSCLC: BRAF V600E mutation
  • Metastatic NSCLC: MET exon 14 skipping
  • Metastatic NSCLC: RET+
  • Metastatic NSCLC: NTRK+
  • Metastatic NSCLC: PD-L1+ (≥50%)
  • Metastatic NSCLC: PD-L1+ (≥1–49%)
  • Metastatic NSCLC: all other
  • Metastatic NSCLC: all other maintenance therapy
  • Metastatic NSCLC: all other second line or later
Epidemiology
  • Incidence methodology
  • Prevalence of common non-small cell lung cancer biomarkers
Marketed Drugs

Pipeline Drugs

Key Regulatory Events
  • English Funding Success for Roche’s Rozlytrek in NSCLC
  • Roche's Tecentriq Notches Approval for First-Line NSCLC Monotherapy
  • Bristol Wins First of Two Important Opdivo/Yervoy First-Line NSCLC Approvals
  • US FDA Dismisses Post-Progression Endpoint in Cyramza Lung Cancer Study
  • Expanded Lung Cancer Claim for Lilly’s Cyramza Faces US FDA Scrutiny
  • Cyramza First-Line Lung Cancer Bid Raises Clinical Practice Questions
  • NICE Rejects Tecentriq for Small-Cell Lung Cancer in England
Probability of Success

Clinical Trial Landscape
  • Sponsors by status
  • Sponsors by phase
  • Recent events
Drug Assessment Model
  • EGFR inhibitors
  • ROS1 and NTRK gene fusions
  • ALK inhibitors
  • KRAS inhibitor
  • BRAF inhibitors
  • RET inhibitors
  • MET inhibitors
  • PD-1/PD-L1 inhibitors
  • TIGIT inhibitor
  • Interleukin 1b antagonist
  • Microtubule inhibitors
  • Folate analog metabolic inhibitor
  • VEGF inhibitors
  • Post-immunotherapy
Market Dynamics

Future Trends
  • Keytruda is forecast to remain the leading immunotherapy approved for NSCLC
  • Checkpoint inhibitors are expected to move into earlier stages of NSCLC
  • Approvals and subsequent uptake for new therapies in the post-immunotherapy setting will contribute significantly to growth in the NSCLC market
  • Alecensa is expected to continue leading the ALK inhibitor class due to strong results in the first-line setting, despite potential competition
  • Tagrisso will remain the best-selling EGFR inhibitor due to continued uptake in the first-line setting and a label expansion in the adjuvant setting
  • New EGFR inhibitors will address the EGFR exon 20 insertion mutation, which is associated with poor response to current treatments
  • The approval and uptake of MET inhibitors is expected to address unmet needs in patients with exon 14 skipping mutations
  • Recent approvals and subsequent uptake of therapies targeting new mutational drivers will support growth in the NSCLC market over the forecast period
  • Generic or biosimilar erosion of key brands will have minimal impact on growth
Consensus Forecasts

Recent Events and Analyst Opinion
  • Tagrisso for NSCLC (May 31, 2020)
  • SAR408701 for NSCLC (May 29, 2020)
  • Sym015 for NSCLC (May 29, 2020)
  • Enhertu for NSCLC (May 29, 2020)
  • Tepotinib for NSCLC (May 29, 2020)
  • Tagrisso for NSCLC (May 29, 2020)
  • Opdivo for NSCLC (May 29, 2020)
  • Tabrecta for NSCLC (May 14, 2020)
  • Tagrisso for NSCLC (May 13, 2020)
  • Tiragolumab for NSCLC (May 13, 2020)
  • Opdivo for NSCLC (May 13, 2020)
  • Enhertu for NSCLC (May 13, 2020)
  • Libtayo for NSCLC (April 27, 2020)
  • Tagrisso for NSCLC (April 10, 2020)
  • Tedopi for NSCLC (April 1, 2020)
  • Cyramza for NSCLC (February 26, 2020)
  • Pegilodecakin for NSCLC (January 30, 2020)
  • Pralsetinib for NSCLC (January 8, 2020)
  • Poziotinib for NSCLC (December 26, 2019)
  • Imfinzi for NSCLC (October 28, 2019)
  • Opdivo for NSCLC (October 22, 2019)
  • Tagrisso for NSCLC (September 28, 2019)
  • Opdivo for NSCLC (September 28, 2019)
  • AMG 510 for NSCLC (September 27, 2019)
  • Tecentriq for NSCLC (September 27, 2019)
  • Tecentriq for NSCLC (September 11, 2019)
  • Imfinzi for NSCLC (August 21, 2019)
  • Tagrisso for NSCLC (August 9, 2019)
  • Opdivo for NSCLC (July 24, 2019)
  • Enoblituzumab for NSCLC (July 10, 2019)
Key Upcoming Events

Key Opinion Leader Insights

Unmet Needs

Bibliography
  • Prescription information
Appendix

List of Figures
Figure 1: Trends in incident cases of NSCLC, 2018–27
Figure 2: Overview of pipeline drugs for NSCLC in the US
Figure 3: Pipeline drugs for NSCLC, by company
Figure 4: Pipeline drugs for NSCLC, by drug type
Figure 5: Pipeline drugs for NSCLC, by classification
Figure 6: Probability of success in the NSCLC pipeline
Figure 7: Clinical trials in NSCLC
Figure 8: Top 10 drugs for clinical trials in NSCLC
Figure 9: Top 10 companies for clinical trials in NSCLC
Figure 10: Trial locations in NSCLC
Figure 11: NSCLC trials status
Figure 12: NSCLC trials sponsors, by phase
Figure 13: The publisher's drug assessment summary for NSCLC
Figure 14: Market dynamics in NSCLC
Figure 15: Future trends in NSCLC
Figure 16: Tagrisso for NSCLC (May 31, 2020): Phase III - ADAURA
Figure 17: SAR408701 for NSCLC (May 29, 2020): Phase I/II - Advanced Solid Tumors
Figure 18: Sym015 NSCLC (May 29, 2020): Phase I/II - Safety
Figure 19: Enhertu for NSCLC (May 29, 2020): Phase II - DESTINY-Lung01
Figure 20: Tepotinib for NSCLC (May 29, 2020): Phase II - VISION (Adenocarcinoma)
Figure 21: Tabrecta for NSCLC (May 14, 2020): Phase II - GEOMETRY mono-1
Figure 22: Tagrisso for NSCLC (May 13, 2020): Phase III - ADAURA
Figure 23: Opdivo for NSCLC (May 13, 2020): Phase III - CheckMate-9LA (Stage IV, w/Ipilimumab)
Figure 24: Enhertu for NSCLC (May 13, 2020): Phase II - DESTINY-Lung01
Figure 25: Libtayo for NSCLC (April 27, 2020): Phase III - vs. Chemotherapy (1st Line)
Figure 26: Tedopi for NSCLC (April 1, 2020): Phase III - ATALANTE-1
Figure 27: Pralsetinib for NSCLC (January 8, 2020): Phase I/II - ARROW (NSCLC, Thyroid, Solids)
Figure 28: Poziotinib for NSCLC (December 26, 2019): Phase II - ZENITH20 (EGFR or HER2 Exon 20 Mut.)
Figure 29: Imfinzi for NSCLC (October 28, 2019): Phase III - POSEIDON (w/Tremelimumab)
Figure 30: Opdivo for NSCLC (October 22, 2019): Phase III - CheckMate 9LA (Stage IV, w/Ipilimumab)
Figure 31: Tagrisso for NSCLC (September 28, 2019): Phase III - FLAURA
Figure 32: Opdivo for NSCLC (September 28, 2019): Phase III – CheckMate 227
Figure 33: AMG 510 for NSCLC (September 27, 2019): Phase I/II - KRAS p.G12C Mutation
Figure 34: Tecentriq for NSCLC (September 27, 2019): Phase III - IMpower 110 (PD-L1 Selected; Non-Sq.; Chemo-Naive)
Figure 35: Tecentriq for NSCLC (September 11, 2019): Phase III - IMpower 110 (PD-L1 Selected; Non-Sq.; Chemo-Naive)
Figure 36: Imfinzi for NSCLC (August 21, 2019): Phase III - NEPTUNE (w/Tremelimumab)
Figure 37: Tagrisso for NSCLC (August 9, 2019): Phase III - FLAURA
Figure 38: Opdivo for NSCLC (July 24, 2019): Phase III - CheckMate 227
Figure 39: Key upcoming events in NSCLC (1 of 3)
Figure 40: Key upcoming events in NSCLC (2 of 3)
Figure 41: Key upcoming events in NSCLC (3 of 3)

List of Tables
Table 1: Five-year survival rates of lung cancer, by stage at diagnosis
Table 2: Non-small cell lung cancer staging and corresponding TNM classifications
Table 3: Preferred branded first-line treatment regimens for patients with Stage IV EGFR+ NSCLC
Table 4: Preferred branded treatment regimens for patients who progress on first- and second-generation EGFR TKIs
Table 5: Preferred branded first- and second-line treatment regimens for patients with Stage IV ALK+ NSCLC
Table 6: Preferred treatment regimens for patients with Stage IV ROS1+ NSCLC
Table 7: Preferred treatment regimens for patients with Stage IV BRAF V600E mutated NSCLC
Table 8: Preferred treatment regimens for patients with Stage IV NSCLC and a MET exon 14 skipping mutation
Table 9: Preferred treatment regimens for patients with Stage IV RET+ NSCLC
Table 10: Preferred treatment regimens for patients with Stage IV NTRK+ NSCLC
Table 11: Preferred branded first-line treatment regimens for patients with advanced NSCLC and PD-L1+ TPS ≥50%
Table 12: Preferred branded first-line treatment regimens for patients with advanced NSCLC and PD-L1+ TPS ≥1–49%
Table 13: Preferred branded first-line treatment regimens for patients with advanced NSCLC
Table 14: Preferred branded second-line or later treatment regimens for patients with metastatic NSCLC
Table 15: Incident cases of NSCLC, 2018–27
Table 16: Incident cases of NSCLC, by gender, 2018
Table 17: Marketed drugs for NSCLC
Table 18: Pipeline drugs for NSCLC
Table 19: Historical global sales, by drug ($m), 2015–19
Table 20: Forecasted global sales, by drug ($m), 2020–24
Table 21: Tagrisso for NSCLC (May 31, 2020)
Table 22: SAR408701 for NSCLC (May 29, 2020)
Table 23: Sym015 for NSCLC (May 29, 2020)
Table 24: Enhertu for NSCLC (May 29, 2020)
Table 25: Tepotinib for NSCLC (May 29, 2020)
Table 26: Tagrisso for NSCLC (May 29, 2020)
Table 27: Opdivo for NSCLC (May 29, 2020)
Table 28: Tabrecta for NSCLC (May 14, 2020)
Table 29: Tagrisso for NSCLC (May 13, 2020)
Table 30: Tiragolumab for NSCLC (May 13, 2020)
Table 31: Opdivo for NSCLC (May 13, 2020)
Table 32: Enhertu for NSCLC (May 13, 2020)
Table 33: Libtayo for NSCLC (April 27, 2020)
Table 34: Tagrisso for NSCLC (April 10, 2020)
Table 35: Tedopi for NSCLC (April 1, 2020)
Table 36: Cyramza for NSCLC (February 26, 2020)
Table 37: Pegilodecakin for NSCLC (January 30, 2020)
Table 38: Pralsetinib for NSCLC (January 8, 2020)
Table 39: Poziotinib for NSCLC (December 26, 2019)
Table 40: Imfinzi for NSCLC (October 28, 2019)
Table 41: Opdivo for NSCLC (October 22, 2019)
Table 42: Tagrisso for NSCLC (September 28, 2019)
Table 43: Opdivo for NSCLC (September 28, 2019)
Table 44: AMG 510 for NSCLC (September 27, 2019)
Table 45: Tecentriq for NSCLC (September 27, 2019)
Table 46: Tecentriq for NSCLC (September 11, 2019)
Table 47: Imfinzi for NSCLC (August 21, 2019)
Table 48: Tagrisso for NSCLC (August 9, 2019)
Table 49: Opdivo for NSCLC (July 24, 2019)
Table 50: Enoblituzumab for NSCLC (July 10, 2019)
Note: Product cover images may vary from those shown
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