Ep 38: TIL v. Ipi
10/14/24 • 34 min
1 Listener
Summary
On the heels of the great ESMO 2024 session with Toni Ribas, Inge Marie Svane, and Olivier Michielin James and Sapna discuss Prof Svane and Prof van Haanen's TIL trial, a significant study in melanoma treatment that explores the efficacy and safety of tumor-infiltrating lymphocyte (TIL) therapy compared to traditional treatments. They delve into the historical context of the trial, its design, the observed efficacy rates, potential side effects, and the implications of sex-based differences in treatment outcomes. The discussion highlights the importance of this trial in shaping future treatment strategies for melanoma and the need for further research in this area.
Keywords
TIL trial, melanoma, cellular therapy, immunotherapy, efficacy, toxicity, first-line treatment, sex-based differences
Takeaways
The TIL trial is a landmark study in melanoma treatment.
TIL therapy shows a near 50% response rate in patients.
The control arm of the trial has faced criticism.
TIL therapy is a viable strategy for patients after PD-1 exposure.
Toxicity profiles of TIL therapy need careful consideration.
There is potential for TIL therapy to be used in first-line treatment.
Sex-based differences in treatment outcomes are significant.
The trial design raises important regulatory questions.
Further research is needed to understand hormonal influences on treatment.
The results of this trial could change treatment paradigms in melanoma.
Sound Bites
"This is the first randomized study of cellular therapy."
"TIL therapy shows a near 50% response rate."
"The control arm has been criticized."
Chapters
00:00 Introduction to the TIL trial
04:08 Discussion on the efficacy of TIL therapy
09:12 Considerations for regulatory approval and future research
11:34 Analysis of toxicity in the TILT trial
15:46 Exploring the potential of TIL therapy in the first-line setting
20:12 Discussion on the feasibility of conducting larger trials with TIL therapy
23:42 Sex-based differences in the response to TIL therapy
27:35 Complexity of studying sex-based differences in cancer treatment
31:04 Conclusion and future implications of the TILT trial
33:07 Impressive Median Dose of Till Cells
33:33 Administration of High-Dose IL-2
Summary
On the heels of the great ESMO 2024 session with Toni Ribas, Inge Marie Svane, and Olivier Michielin James and Sapna discuss Prof Svane and Prof van Haanen's TIL trial, a significant study in melanoma treatment that explores the efficacy and safety of tumor-infiltrating lymphocyte (TIL) therapy compared to traditional treatments. They delve into the historical context of the trial, its design, the observed efficacy rates, potential side effects, and the implications of sex-based differences in treatment outcomes. The discussion highlights the importance of this trial in shaping future treatment strategies for melanoma and the need for further research in this area.
Keywords
TIL trial, melanoma, cellular therapy, immunotherapy, efficacy, toxicity, first-line treatment, sex-based differences
Takeaways
The TIL trial is a landmark study in melanoma treatment.
TIL therapy shows a near 50% response rate in patients.
The control arm of the trial has faced criticism.
TIL therapy is a viable strategy for patients after PD-1 exposure.
Toxicity profiles of TIL therapy need careful consideration.
There is potential for TIL therapy to be used in first-line treatment.
Sex-based differences in treatment outcomes are significant.
The trial design raises important regulatory questions.
Further research is needed to understand hormonal influences on treatment.
The results of this trial could change treatment paradigms in melanoma.
Sound Bites
"This is the first randomized study of cellular therapy."
"TIL therapy shows a near 50% response rate."
"The control arm has been criticized."
Chapters
00:00 Introduction to the TIL trial
04:08 Discussion on the efficacy of TIL therapy
09:12 Considerations for regulatory approval and future research
11:34 Analysis of toxicity in the TILT trial
15:46 Exploring the potential of TIL therapy in the first-line setting
20:12 Discussion on the feasibility of conducting larger trials with TIL therapy
23:42 Sex-based differences in the response to TIL therapy
27:35 Complexity of studying sex-based differences in cancer treatment
31:04 Conclusion and future implications of the TILT trial
33:07 Impressive Median Dose of Till Cells
33:33 Administration of High-Dose IL-2
Previous Episode
Ep 37: CheckMate 511
Summary
In this episode of Melanoma Matters, host James Larkin uses his 1-800-Operator voice until co-host Sapna Patel reminds him to use his podium voice. There is a noisy wardrobe choice (SP) and a fact check of a fact check (JL).
Sapna and James have an in-depth conversation of the Checkmate 511 study, discussing its implications for treatment regimens in melanoma. They delve into the nuances of type 1 and type 2 errors, analyze the results of the study, and consider the long-term follow-up data. The conversation also explores global perspectives on treatment practices and the importance of understanding toxicity and efficacy in clinical settings.
Keywords
Checkmate 511, melanoma, type 1 error, type 2 error, treatment regimens, efficacy, toxicity, global perspectives, long-term follow-up, clinical practice
Takeaways
Checkmate 511 is a widely cited study in melanoma treatment.
Type one error relates to the alpha of the study, while type two error is related to sample size.
The study showed a lower incidence of grade 3 to 5 AEs with Nivo 3 - Ipi 1 compared to Nivo 1 -Ipi 3.
Long-term follow-up is crucial for understanding the efficacy of treatment regimens.
Global perspectives on treatment regimens vary, especially regarding reimbursement and labeling.
The study's findings have influenced practice in the U.S., despite a lack of formal publication.
Concerns remain about the efficacy of lower doses in specific patient populations, such as those with brain metastases.
The conversation highlights the importance of ongoing research and follow-up studies in melanoma treatment.
Understanding statistical errors is essential for interpreting clinical trial results.
The hosts express a desire for more comprehensive data and follow-up on the Checkmate 511 study.
Sound Bites
"This is a fact check of a fact check."
"Type one error is related to the alpha of a study."
"The incidence of grade 3 to 5 AEs was 34% with Nivo 3 -Ipi 1."
Chapters
00:00 Introduction and Volume Issues
04:50 Overview of Checkmate 511 Study
09:59 Concerns about Lack of Published Follow-Up Data
16:00 Demographics and Subgroups in Checkmate 511 Study
16:44 Implementation of Inverted Dosing Regimen Globally
19:01 Caution and Considerations with Inverted Dosing Regimen
23:45 Fact Check
25:08 Comparing Regimens in the BRAF Mutant Population
29:16 Fact-Checking 'Up in the Air'
29:50 Fact Check of a Fact Check (BRAF)
Next Episode
Ep 39: LEAP 004 & 003
Summary
(Coach) Owen is in a seriously bad mood with James at the moment! But James is back in pull-up form and can do an impressive number of strict pull-ups...
In this episode, Sapna Patel and James Larkin discuss the LEAP 004 and LEAP 003 studies, focusing on the combination of lenvatinib and pembrolizumab in treating melanoma, particularly in patients who are refractory to PD-1 inhibitors. They explore the efficacy, safety, and implications of these studies, as well as the challenges in treatment guidelines and future directions for research in this area.
Keywords
melanoma, LEAP 004, lenvatinib, pembrolizumab, clinical trials, cancer treatment, efficacy, safety, guidelines
Takeaways
The LEAP 004 study showed a 21.4% response rate.
Lenvatinib is a multi-targeted VEGF receptor inhibitor with potential in melanoma.
The combination of lenvatinib and pembrolizumab may increase sensitivity to PD-1 inhibitors.
Toxicity is a significant concern with the lenvatinib and pembrolizumab combination.
LEAP 003 did not demonstrate an improvement in overall survival compared to pembrolizumab alone.
The efficacy of lenvatinib in melanoma is still being evaluated in refractory settings.
There is a need for further studies to understand the mechanisms of resistance to PD-1 therapy.
Guidelines for treatment may vary significantly between jurisdictions.
Patient perspectives on treatment and toxicity are crucial in clinical practice.
The future of lenvatinib and pembrolizumab in melanoma treatment remains uncertain.
Sound Bites
"What's your number of kilos you're deadlifting?"
"Lenvatinib has been around for a while."
"The unmet need we all know, which is anti PD-1 refractory melanoma."
Chapters
00:00 Introduction and Discussion of Deadlifting
03:31 Overview of Leap004 Study and Rationale for Lenvatinib
09:22 Promising Results in Leap004 Study
15:59 Discontinuation of Leap003 Trial
19:33 Challenges with Dosing and Toxicity of Lenvatinib
22:00 Uncertainty in the Use of Lenvatinib-Pembrolizumab in PD-1 Refractory Patients
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