Disease Analysis: NHL: Follicular Lymphoma
Author: Tom Tyler
Publisher: Datamonitor Healthcare
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Disease Overview
Follicular lymphoma (FL) is an indolent subtype of non-Hodgkin’s lymphoma (NHL) specifically originating from centrocyte and centroblast B cells and usually beginning in the lymph nodes. The disease is among the most common forms of NHL alongside diffuse
large B-cell lymphoma (DLBCL), accounting for approximately 35% of all NHLs.
Latest key takeaways
- Follicular lymphoma (FL) is an indolent subtype of non-Hodgkin’s lymphoma (NHL) specifically originating from centrocyte and centroblast B cells and usually beginning in the lymph nodes. The disease is among the most common forms of NHL alongside diffuse large B-cell lymphoma (DLBCL), accounting for approximately 35% of all NHLs.
- Datamonitor Healthcare estimates that in 2018, there were 70,800 incident cases of follicular lymphoma (FL) worldwide, and expects that number to increase to 76,600 incident cases by 2027.
- Despite being essentially incurable, FL progresses very slowly, meaning that five-year survival rates are relatively high. Treatments are largely intended to drive the disease into remission until recurrence, at which point another round of therapy will be required.
- Since its approval in 1997, most recommended regimens, particularly in the first-line setting, combine the CD20 antagonist Rituxan with chemotherapy. Rituximab biosimilars are now widely available.
- Another CD20 antibody, Gazyva, has also found modest success in early lines of therapy.
- Most pipeline development concerns therapies for heavily pretreated disease. Notable innovations in this space include PI3K inhibitors, BTK inhibitors, bispecific T-cell engagers (BiTEs), and anti-CD19 CAR-T therapies.
- PI3K inhibitors, represented in FL by Copiktra, Aliqopa, Zydelig, and Ukoniq, have raised toxicity concerns. However, Copiktra and Ukoniq, the more recently approved of the four, show more manageable safety profiles. These are expected to be joined by the next-generation PI3K antagonists parsaclisib and zandelisib.
- Yescarta, recently approved in third-line disease, has become the first CAR-T therapy in FL. It is expected to shortly be followed by Kymriah. Monjuvi, a third CD19-targeted CAR-T, is also entering late-phase development.
- Odronextamab and mosunetuzumab, BiTEs targeting CD20 and CD3, present an opportunity to improve upon the mechanism of anti-CD20 monoclonal antibodies in second-line disease, where they have remained the standard of care for decades.
- In an immunoradiotherapy platform similar to that of Zevalin, Betalutin uses a CD37 antibody conjugated to a radionuclide of luteium-177 to destroy cancer cells with radiation in a targeted manner. As the first CD37-targeted agent, this approach may be useful for highly refractory patients, but may struggle to compete in a very crowded field.
- BTK inhibitors include Beigene’s Brukinsa and AbbVie’s Imbruvica. Datamonitor Healthcare expects Imbruvica to be the more successful of these two pipeline assets.
- Also seeking to position themselves as alternatives to anti-CD19 CAR-Ts in heavily pretreated disease are a pair of developmental CD19 antibodies, Monjuvi and Zynlonta.
- The overall likelihood of approval of a Phase I indolent NHL (including FL) asset is 14.7%, and the average probability that a drug advances from Phase III is 52.6%; both of these figures are higher than the average seen across oncology indications. Drugs, on average, take 9.2 years from Phase I to approval, which is faster than the 9.6-year average in the overall oncology space.
CONTENTS
7 OVERVIEW
7 Latest key takeaways
9 DISEASE BACKGROUND
9 Definition
9 Risk factors
9 Symptoms
10 Diagnosis
10 Patient segmentation
12 Prognosis
13 TREATMENT
13 Standard therapeutic techniques
13 Recommended first-line pharmacological regimens
14 Recommended subsequent-line pharmacological regimens
18 EPIDEMIOLOGY
18 Incidence methodology
21 MARKETED DRUGS
27 PIPELINE DRUGS
36 KEY REGULATORY EVENTS
36 Two Review Tracks, One Approval For TG’s Ukoniq
36 Yescarta Becomes Japan’s Second Approved CAR-T
36 Regenerative Medicine Comes Of Age – In The Age Of COVID-19
36 Mylan Obtains CHMP Backing For Revlimid Generic In Two Indications
37 Lilly And Innovent’s Rituximab Gets Chinese Nod
37 US FDA Oncology Applications: Real-Time Review And Breakthrough Pathway Show Durable Appeal
37 Review Of BMS’s CAR-T Therapy Liso-Cel Gets Under Way At EMA
37 Tazverik Accelerated Approval: Disease Rarity And Unmet Need Won Out Over Efficacy Concerns
39 PROBABILITY OF SUCCESS
40 CLINICAL TRIAL LANDSCAPE
42 Sponsors by status
42 Sponsors by phase
43 Recent events
45 DRUG ASSESSMENT MODEL
48 MARKET DYNAMICS
49 FUTURE TRENDS
49 Proliferation of novel therapies in relapsed/recurrent disease
49 Rituximab to remain staple treatment in front-line patients
50 Potential changes to second-line treatment landscape
51 CONSENSUS FORECASTS
56 RECENT EVENTS AND ANALYST OPINION
56 Aliqopa for Indolent Non-Hodgkin’s Lymphoma (Including Follicular Lymphoma) – NHL (April 10, 2021)
58 Odronextamab for Indolent Non-Hodgkin’s Lymphoma (Including Follicular Lymphoma) – NHL (December 14, 2020)
60 Ukoniq for Indolent Non-Hodgkin’s Lymphoma (Including Follicular Lymphoma) – NHL (December 07, 2020)
61 Parsaclisib for Indolent Non-Hodgkin’s Lymphoma (Including Follicular Lymphoma) – NHL (December 07, 2020)
63 Kymriah for Indolent Non-Hodgkin’s Lymphoma (Including Follicular Lymphoma) – NHL (December 05, 2020)
64 Yescarta for Indolent Non-Hodgkin’s Lymphoma (Including Follicular Lymphoma) – NHL (December 05, 2020)
65 HMPL-689 for Indolent Non-Hodgkin’s Lymphoma (Including Follicular Lymphoma) – NHL (December 05, 2020)
66 Aliqopa for Indolent Non-Hodgkin’s Lymphoma (Including Follicular Lymphoma) – NHL (October 14, 2020)
69 KEY UPCOMING EVENTS
70 BIBLIOGRAPHY
71 APPENDIX
LIST OF FIGURES
11 Figure 1: Lugano Staging Classification for follicular lymphoma
12 Figure 2: Incidence rate and death rate of follicular lymphoma in the US, 1992–2018
14 Figure 3: Recommended first-line therapies for follicular lymphoma
15 Figure 4: Recommended subsequent-line therapies for follicular lymphoma
20 Figure 5: Trends in incident cases of follicular lymphoma, 2018–27
27 Figure 6: Overview of pipeline drugs for follicular lymphoma in the US
28 Figure 7: Pipeline drugs for follicular lymphoma, by company
28 Figure 8: Pipeline drugs for follicular lymphoma, by drug type
29 Figure 9: Pipeline drugs for follicular lymphoma, by classification
39 Figure 10: Probability of success in the indolent NHL (including follicular lymphoma) pipeline
40 Figure 11: Clinical trials in non-Hodgkin’s lymphoma
40 Figure 12: Top 10 drugs for clinical trials in non-Hodgkin’s lymphoma
41 Figure 13: Top 10 companies for clinical trials in non-Hodgkin’s lymphoma
41 Figure 14: Trial locations in non-Hodgkin’s lymphoma
42 Figure 15: Non-Hodgkin’s lymphoma trials status
43 Figure 16: Non-Hodgkin’s lymphoma trials sponsors, by phase
45 Figure 17: Datamonitor Healthcare’s drug assessment summary for follicular lymphoma
48 Figure 18: Market dynamics in follicular lymphoma
49 Figure 19: Future trends in follicular lymphoma
58 Figure 20: Aliqopa for Indolent Non-Hodgkin’s Lymphoma (Including Follicular Lymphoma) – NHL (April 10, 2021): Phase III – CHRONOS-3
61 Figure 21: Ukoniq for Indolent Non-Hodgkin’s Lymphoma (Including Follicular Lymphoma) – NHL (December 07, 2020): Phase II/III – UNITY-NHL
63 Figure 22: Parsaclisib for Indolent Non-Hodgkin’s Lymphoma (Including Follicular Lymphoma) – NHL (December 07, 2020): Phase II – CITADEL-203 (vs. Idelalisib)
68 Figure 23: Aliqopa for Indolent Non-Hodgkin’s Lymphoma (Including Follicular Lymphoma) – NHL (October 14, 2020): Phase III – CHRONOS-3
69 Figure 24: Key upcoming events in follicular lymphoma
LIST OF TABLES
12 Table 1: WHO histologic grading system for follicular lymphoma
16 Table 2: Recommended branded treatment regimens for follicular lymphoma
19 Table 3: Incident cases of follicular lymphoma, 2018–27
22 Table 4: Marketed drugs for follicular lymphoma
30 Table 5: Pipeline drugs for follicular lymphoma in the US
52 Table 6: Historical global sales, by drug ($m), 2016–20
55 Table 7: Forecasted global sales, by drug ($m), 2021–25
56 Table 8: Aliqopa for Indolent Non-Hodgkin’s Lymphoma (Including Follicular Lymphoma) – NHL (April 10, 2021)
59 Table 9: Odronextamab for Indolent Non-Hodgkin’s Lymphoma (Including Follicular Lymphoma) – NHL (December 14, 2020)
60 Table 10: Ukoniq for Indolent Non-Hodgkin’s Lymphoma (Including Follicular Lymphoma) – NHL (December 07, 2020)
62 Table 11: Parsaclisib for Indolent Non-Hodgkin’s Lymphoma (Including Follicular Lymphoma) – NHL (December 07, 2020)
64 Table 12: Kymriah for Indolent Non-Hodgkin’s Lymphoma (Including Follicular Lymphoma) – NHL (December 05, 2020)
65 Table 13: Yescarta for Indolent Non-Hodgkin’s Lymphoma (Including Follicular Lymphoma) – NHL (December 05, 2020)
66 Table 14: HMPL-689 for Indolent Non-Hodgkin’s Lymphoma (Including Follicular Lymphoma) – NHL (December 05, 2020)
67 Table 15: Aliqopa for Indolent Non-Hodgkin’s Lymphoma (Including Follicular Lymphoma) – NHL (October 14, 2020)
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