Lisa Astor is the Associate Editorial Director for Targeted Oncology. Astor received her Bachelor of Arts in English Literature from New York University.

Lisa Astor

Targeted therapy use in melanoma has been extended beyond just metastatic disease to now include adjuvant therapy for patients with resected stage III melanoma. 

Adjuvant targeted therapy use in melanoma has had the most impact thus far on 

-mutant disease, as approximately 35% to 40% of melanoma cases are 

 mutant. The majority of these mutations are V600E and are found in younger patients with melanoma, explained Georgina V. Long, AO, PhD, MBBS, BSc, in a presentation during the 10th World Congress of Melanoma & 17th EADO Congress held virtually in April.

 In addition, approximately 20% of patients with melanoma harbor 

The seminal trial that showed benefit for adjuvant targeted therapy in 

-mutant melanoma was the phase 3 COMBI-AD trial (NCT01682083). It looked at the use of adjuvant dabrafenib (Tafinlar) and trametinib (Mekinist) in comparison with placebo in patients with stage IIIA-IIIC resected cutaneous melanoma harboring a 

In the primary analysis, the relapse-free survival (RFS) rate at 3 years was 58% with dabrafenib/trametinib and 39% with placebo (HR, 0.47; 95% CI, 0.39-0.58; 

 < .00001).3 The 5-year analysis for the trial showed that RFS benefit persisted over time, with a 5-year RFS rate of 52% versus 36% for dabrafenib/trametinib and placebo, respectively (HR, 0.51; 95% CI, 0.42-0.61).

“Twelve months of treatment gives us a 50% reduction in risk of recurrence,” noted Long, co–medical director and chair of melanoma medical oncology and translational research at Melanoma Institute Australia at the University of Sydney and Royal North Shore Hospital. This reduction was greater than the risk reduction seen with either adjuvant nivolumab (Opdivo; HR, 0.67) or pembrolizumab (Keytruda; HR, 0.57).

The RFS benefit with dabrafenib/trametinib also was seen across all subgroups at both time points.

The distant metastasis-free survival rate was 71% in the dabrafenib/trametinib arm at 3 years and 65% at 5 years. In the placebo arm, the distant metastasis-free survival rate at 3 years was 57% and 54% at 5 years.

“We know that anti–PD-1 therapy has also been examined in the adjuvant setting. However, what we don’t know is whether we need to treat now or whether we could wait until stage IV,” Long said. “At the moment, the standard is to resect the disease and treat with 12 months of adjuvant therapy. But what if we resected the disease, watched, and only treated when patients had a recurrence or were stage IV? Do we actually end up with the same overall survival and quality of life?”

Long pointed out that the adjuvant combination of dabrafenib and trametinib was the only FDA-approved adjuvant regimen to provide a suggestion of overall survival (OS) benefit in melanoma. In the COMBI-AD study, the 3-year OS rate with the combination was 86% and 77% with placebo (HR, 0.57; 95% CI, 0.42-0.79; 

 = .0006). However, the P value did not cross the prespecified significance threshold.

The investigators found that with tumor mutational burden (TMB) and interferon-γ (IFN-γ) gene expression signatures, all groups, except for patients with high TMB and low IFN-γ scores, benefited more from the combination of dabrafenib/trametinib than from placebo.

Long suggested this was because these patients had many mechanisms of resistance to targeted therapy but without the immune engagement that leads to a better prognosis.

When patients in the study had a recurrence, 54% in the placebo arm developed a distant recurrence. In the dabrafenib/trametinib arm, however, 62% of patients had a distant recurrence. Long noted that investigators are seeking to determine whether this is related to more brain metastases with adjuvant targeted therapy compared with adjuvant immunotherapy or if this is just related to the characteristics of the disease.

Adjuvant Targeted Therapy Versus Immunotherapy 

Long compared the RFS rates from the COMBI-AD trial with that of the CheckMate 238 trial (NCT02388906) to compare adjuvant targeted therapy with immunotherapy. At 1 year, the RFS rates were 86% with dabrafenib/trametinib, 72% with nivolumab, 62% with ipilimumab (Yervoy), and 51% with no therapy.

 She commented that the curves were similar to what is seen in stage IV melanoma as well.

At 2 years, however, the RFS rate for dabrafenib/trametinib drops slightly below that of nivolumab (63% vs 64%, respectively). Long cautioned that not all patients in the CheckMate 238 trial had a 

In the KEYNOTE-054 study (NCT02362594) of adjuvant pembrolizumab versus placebo in patients with resected stage III melanoma, among patients with 

 V600E/K–mutated melanoma, the 3-year RFS rate was 62.0% with pembrolizumab and 37.1% with placebo (HR, 0.51; stratified log-rank 

 This compared similarly with the RFS curves in the COMBI-AD trial. In patients with 

 wild-type disease, however, the difference was narrower at 61.8% versus 46.5% for pembrolizumab and placebo, respectively (HR, 0.66; stratified log-rank 

“Let’s watch this space,” Long stressed. “We can’t really make a decision [yet] about how we will compare these therapies, but we must remember to compare similar patients.”

1. Long GV. Adjuvant targeted therapy in melanoma. Presented at: 10th World Congress of Melanoma & 17th EADO Congress; April 15-17, 2021; virtual. 

2. Menzies AM, Haydu LE, Visintin L, et al. Distinguishing clinicopathologic features of patients with V600E and V600K BRAF-mutant metastatic melanoma. 

. 2012;18(12):3242-3249. doi:10.1158/10780432.CCR-12-0052 

3. Long GV, Hauschild A, Santinami M, et al. Adjuvant dabrafenib plus trametinib in stage III BRAF-mutated melanoma.

. 2017;377(19):1813-1823. doi:10.1056/NEJMoa1708539 

4. Dummer R, Hauschild A, Santinami M, et al. Five-year analysis of adjuvant dabrafenib plus trametinib in stage III melanoma. 

. 2020;383(12):1139-1148. doi:10.1056/NEJMoa2005493 

5. Weber J, Mandala M, Del Vecchio M, et al; CheckMate 238 Collaborators. Adjuvant nivolumab versus ipilimumab in resected stage III or IV melanoma. 

. 2017;377(19):1824-1835. doi:10.1056/NEJMoa1709030 

6. Eggermont AMM, Blank CU, Mandala M, et al. Adjuvant pembrolizumab versus placebo in resected stage III melanoma. 

. 2018;378(19):1789-1801. doi:10.1056/NEJMoa1802357 

7. Dummer R, Brase JC, Garrett J, et al. Adjuvant dabrafenib plus trametinib versus placebo in patients with resected, BRAF V600-mutant, stage III melanoma (COMBI-AD): exploratory biomarker analyses from a randomised, phase 3 trial. 

. 2020;21(3):358-372. doi:10.1016/ S1470-2045(20)30062-0 

8. Eggermont AM, Blank CU, Mandala M, et al. Pembrolizumab versus placebo after complete resection of high-risk stage III melanoma: new recurrence-free survival results from the EORTC 1325-MG/Keynote 054 double-blinded phase III trial at three-year median follow-up. 

. 2020;38(suppl 15):10000. doi:10.1200/JCO.2020.38.15_suppl.10000

Articles

Targeted therapy use in melanoma has been extended beyond just metastatic disease to now include adjuvant therapy for patients with resected stage III melanoma.


Adjuvant Targeted Therapy Proves Beneficial in Resected Stage III BRAF-Mutant Melanoma

Naratuximab emtansine (Nara; Debio 1562, formerly IMGN529) in combination with rituximab (Rituxan) showed deep responses and a duration of response that was not reached in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), according to findings from a phase 2 trial (NCT02564744) presented during the European Hematology Association (EHA) 2021 Virtual Congress.1

Moshe Yair Levy, MD, director of hematologic malignancies research, Texas Oncology-Baylor Charles A. Sammons Cancer Center, suggested during the presentation that the combination regimen could be a new treatment option for patients with relapsed/refractory DLBCL, including frail and heavily pretreated patients.

Naratuximab emtansine is an antibody-drug conjugate (ADC) comprised of the humanized anti-CD37 antibody K7153A, which is conjugated through a thioether-based linked to the cytotoxic maytansinoid DM1. CD37 is a surface marker on B lymphocytes and is highly expressed in non-Hodgkin lymphomas (NHLs). “It’s also an intern Thierry Facon, MD alizable cell surface antigen, which lends itself well to an antibody-drug construct,” Levy noted. “Nara is the most advanced CD37-targeted antibody-drug conjugate in clinical development in diffuse large B-cell lymphoma.”

Previously in a phase 1 study (NCT01534715), naratuximab emtansine monotherapy showed a manageable safety profile and an objective response rate (ORR) of 22% in patients with DLBCL.2

“But what they found is that if you co-administer this ADC with rituximab, you're actually going to get more internalization of the CD37 monoclonal antibody, therefore more payload delivered to your target cells. So, this led to this phase 2 study,” Levy said.

The open-label, multicenter phase 2 study had an adaptive design.1 The safety run-in in part 1 included patients with relapsed/refractory NHL, including 9 with DLBCL and 8 with other NHLs. Patients were treated with 0.7 mg/kg naratuximab emtansine every 3 weeks on day 1 of the cycle followed by rituximab 375 mg/m2. This was followed by a run-in expansion with 2 cohorts including 8 patients with relapsed/refractory DLBCL in cohort 1 and 12 patients with other NHLs in cohort 2, all treated at the same schedule.

In part 2 of the study, only patients with DLBCL were enrolled and were treated with different dose schedules in the 2 cohorts. In cohort A, 33 patients were treated at the same every 3 week schedule and in cohort B, 30 patients were treated on a weekly schedule with 0.4 mg/kg naratuximab emtansine on day 1 of the 3-week cycle as well as on days 8 and 15 at 0.2 mg/kg followed by rituximab 375 mg/m2 on day 1.

ORR by Lugano classification was the primary end point, and other trial objectives were safety in terms of treatment-emergent adverse events (TEAEs), changes in laboratory tests, and changes in ECG and vital signs.

The overall trial enrolled patients with an ECOG performance status of 0 to 2 who had received 1 to 6 prior lines of treatment. Those with central nervous system (CNS) lymphomas were excluded, but patients with double- or triple-hit lymphoma, bulky disease, and transformed lymphoma were eligible for enrollment. Additionally, there were no limits on life expectancy in the trial, so it was “a very inclusive type of study,” according to Levy.

In part 1, patients were required to have a confirmed diagnosis of relapsed/refractory NHL, including DLBCL, follicular lymphoma, mantle cell lymphoma, and marginal zone lymphoma. Prior allogeneic stem cell transplant was not allowed. Then in part 2, patients were required to have a confirmed diagnosis of relapsed/refractory DLBCL and ineligibility for stem cell transplant.

Patients in the study ranged from 29 to 88 years old and were mostly male with Ann Arbor stage III or IV disease and extra-nodal disease involvement. In patients with DLBCL treated with the every-3-week schedule, the median number of prior therapies was 2, and 1 among patients treated with the weekly regimen. Forty percent of patients were refractory to their last treatment in the every-3-week group and 13.3% were refractory in the weekly group.

As of data cutoff on January 13, 2021, 36.0% of patients with DLBCL treated every 3 weeks in cohort A had completed ≥6 cycles of treatment, as did 50% treated with weekly naratuximab emtansine in cohort B, and 60% of patients with NHL treated every 3 weeks in cohort 2. After 6 cycles, patients could request an extension.

The median number of treatment cycles was 3 (range, 1-38) in cohort A, 5.5 (range, 1-30) in cohort B, and 7 (range, 1-52) in cohort 2. Discontinuation of both drugs—as protocol designated that if naratuximab emtansine was to be discontinued, rituximab would be as well—was primarily due to progressive disease across the study groups; adverse events leading to death were reported in 2 patients.

Of the 76 evaluable patients with DLBCL, the ORR was 44.7% and complete responses (CRs) were reported in 31.6%. In cohort A, the ORR was 50% and CRs were observed in 43.3%. In cohort B, the ORR was also 50% and CRs were reported in 33.3%.

Among patients with non-bulky DLBCL, the ORR was 50.8%. Patients treated in the third line or beyond who were not primary refractory showed an ORR of 46.4% and a CR rate of 32.1%.

The median duration of response was not reached after a median of 15 months of follow-up (95% CI, 9-18). Sixty-six percent of responders had a response lasting more than a year.

Grade 3/4 TEAEs were mostly hematologic and manageable, including most commonly neutropenia (54.0%), leukopenia (19.0%), lymphopenia (17.0%), and thrombocytopenia (12.0%). Additionally, 3 grade ≥3 liver TEAEs and 2 grade ≥3 non-serious neuropathy cases were reported.

He noted that no granulocyte colony stimulating factor was mandated in the trial; “if it was, we probably would have seen a difference in the toxicity profile from the complication of cytopenias.”

Grade 5 TEAEs were reported in 10 patients, only 2 of these, however, were considered related to treatment. Common serious adverse events included pneumonia/lung infection (5.0%), febrile neutropenia (4.0%), and general physical health deterioration (3.0%). Eight patients discontinued treatment due to a TEAE and 6 patients required a dose reduction.

“[This] speaks to just how fragile this group of patients was, and the rather liberal inclusion criteria that allowed people irrespective of the amount of time we thought they had left,” Levy said.

“This is, in my viewpoint, very exciting therapy,” Levy said. “Clearly we have a need for another target in diffuse large B-cell lymphoma, and this certainly seems to compare quite favorably to other ADCs that we have seen in the space.”

1. Levy MY, Grudeva-Popova Z, Trneny M, et al. Safety and efficacy of CD37-targeting naratuximab emtansine plus rituximab in diffuse large b-cell lymphoma and other non-hodgkin’s b-cell lymphomas – a phase 2 study. Presented at: 2021 EHA Congress; June 9-17, 2021; Virtual. Abstract LBA1903.

2. Stathis A, Flinn IW, Madan S, et al. Safety, tolerability, and preliminary activity of IMGN529, a CD37-targeted antibody-drug conjugate, in patients with relapsed or refractory B-cell non-Hodgkin lymphoma: a dose-escalation, phase I study. 

2018;36(5):869-876. doi:10.1007/s10637-018-0570-4

Naratuximab emtansine in combination with rituximab showed deep responses and a duration of response that was not reached in patients with relapsed or refractory diffuse large B-cell lymphoma, according to findings from a phase 2 trial presented during the EHA 2021 Virtual Congress.

Naratuximab Emtansine With Rituximab Leads to Durable Responses in R/R DLBCL

Updated findings for belzutifan (MK-6482) showed that with further follow-up, the hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor continues to show significant clinical activity in patients with Von-Hippel Lindau (VHL)–associated renal cell carcinoma (RCC) treated in the frontline setting. Updated results from the phase 2 study (NCT03401788) were presented in a poster during the 2021 ASCO Annual Meeting.

The study authors, led by Ramaprasad Srinivasan, MD, PhD, noted that the agent also showed efficacy against other VHL-associated neoplasms.

“This update continues to demonstrate the activity of belzutifan in patients with VHL-associated renal and non-renal tumors accompanied by an acceptable safety profile,” said Srinivasan, head of the Molecular Cancer Therapeutics Section, Center for Cancer Research, National Cancer Institute.

Recently, the FDA granted belzutifan a priority review for the treatment of patients with VHL disease–associated RCC who do not require immediate surgery based on earlier results of this study.

The open-label, single-arm study enrolled 61 patients who were diagnosed with VHL disease based on germline alteration who had at least 1 measurable RCC tumor, had not received any prior systemic anticancer therapy, did not have metastatic disease, and had an ECOG performance status of 0 or 1. Patients were treated with 120 mg oral daily belzutifan as a potential systemic treatment for VHL-associated RCC and other VHL neoplasms.

Objective response rate (ORR) in RCC tumors per RECIST criteria by independent review committee was the primary end point and secondary end points included ORR in non-RCC neoplasms, duration of response (DOR), and safety.

The median age was 41 years (range, 19-66) at baseline and the majority of patients were male (52.5%) and had an ECOG performance status of 0 (82.0%). Pancreatic lesions were also reported in all patients, 36.1% of which were neuroendocrine; central nervous system (CNS) hemangioblastomas were reported in 82.0% of patients and retinal lesions in 26.2%.

As of data cutoff, a median of 21.8 months (range, 20.2-30.1) after enrollment, 88.5% of patients were still receiving treatment.

Responses in target RCC lesions were observed in 30 patients (49.2%; 95% CI, 36.1%-62.3%) of patients by independent review committee; all responses were partial responses (PRs), and another 4 patients had unconfirmed PRs. Stable disease was reported in 49.2% of patients and 1 patient was not evaluable. Ninety-two percent of patients had a decrease in target RCC lesion size.

The median time to response was 8.2 months (range, 2.7-19.1) and the duration of response was not reached (range, 2.8+ to 22.3+). Progression-free survival rate at 12 months was 98.3% and 96.5% at 24 months, and the median has not yet been reached.

In pancreatic lesions, responses were reported in 77.0% (95% CI, 64.5%-86.8%), with complete responses (CRs) in 9.8% and PRs in 67.2%. Among pancreatic neuroendocrine tumors, the ORR was 90.9% (95% CI, 70.8%-98.9%) with CRs in 13.6% and PRs in 77.3%. The ORR was 30.0% (95% CI, 17.9%-44.6%) in CNS hemangioblastomas with CRs in 6.0% and PRs in 24.0%.

Srinivasan noted that retinal hemangioblastomas were not amenable to classic response evaluation with RECIST criteria. Sixty-nine percent of retinal hemangioblastomas were improved and 31% were stable as best response.

All patients reported a treatment-related adverse event (TRAE) of any grade, grade 3 events were observed in 32.8% and grade 4 or 5 events in 14.8%. TRAEs led to discontinuation in 1.6% of patients and an adverse event led to death in 1 patient, but the event was not treatment related.

The most common AEs of any grade were anemia (90.2%), fatigue (65.6%), headache (41.0%), dizziness (39.3%), and nausea (34.4%). Most of the events were grade 1 or 2, but common grade 3 events were anemia (8.2%) and hypertension (8.2%). Srinivasan said that anemia was a predicted on-target effect of HIF-2–dependent downregulation of erythropoietin.

1. Srinivasan R, Donskov F, Iliopoulos O, et al. Phase 2 study of belzutifan (MK-6482), an oral hypoxia-inducible factor 2α (HIF-2α) inhibitor, for Von Hippel-Lindau (VHL) disease-associated clear cell renal cell carcinoma (ccRCC). 

2021;39(suppl 15):4555. doi:10.1200/JCO.2021.39.15_suppl.4555

2. Merck Receives Priority Review from FDA for New Drug Application for HIF-2α Inhibitor Belzutifan (MK-6482). News release. Merck. March 16, 2021. Accessed June 7, 2021. https://bit.ly/38NLYM2

Updated findings for belzutifan showed that with further follow-up, the hypoxia-inducible factor-2 alpha inhibitor continues to show significant clinical activity in patients with Von-Hippel Lindau–associated renal cell carcinoma treated in the frontline setting. Updated results from the phase 2 study.

Belzutifan Shows Strong Responses in RCC and Other VHL-Associated Lesions

With further follow-up, lifileucel (LN-144) continued to show durable responses in patients with heavily pretreated advanced or metastatic melanoma who have progressed on multiple therapies, including prior anti–PD-1/PD-L1 therapy, according to updated results from a cohort of the phase 2 C-144-01 trial (NCT02360579) presented at the 2021 ASCO Annual Meeting.

At 33.1 months follow-up with a data cutoff of April 22, 2021, the median duration of response (DOR) still had not been reached (range, 2.2-38.5+ months).

Additionally, treatment with lifileucel was found to be more beneficial among patients with melanoma who had primary resistance to prior anti–PD-1/PD-L1 therapy or a shorter duration of treatment with anti–PD-1/PD-L1 therapy.

“All newly diagnosed patients should be closely monitored for progression on anti–PD-1 therapy. Early intervention with lifileucel at the time of initial progression on anti–PD-1 agents may maximize the benefit,” said James M. G. Larkin, MD, FRCP, PhD, of the Royal Marsden Hospital NHS and Foundation Trust, when presenting the findings.

Similar to prior results presented at the 2021 AACR Annual Meeting,

 the objective response rate (ORR) was 36.4% of patients (24/66), consisting of complete response (CR) in 4.5% and partial response (PR) in 31.8% of patients. Twenty-nine patients (43.9%) had stable disease for a disease control rate of 80.3%.

Eighty-one percent of patients (50/62) had a reduction in tumor burden, and 11 patients (17.7%) had a deepening of response from an earlier data cutoff point. One PR even converted to a CR 2 years after treatment.

Among responders, 79% had received prior ipilimumab (Yervoy) and 46% had received a combination of anti–PD-1 and anti–CTLA-4 therapy. One patient that Larkin called attention to had progressed on 4 prior treatment regimens but with lifileucel he achieved a PR at day 42 that became a CR by day 84, which was still ongoing as of data cutoff.

By univariate analysis, ORR was not predicted by any patient or disease characteristics analyzed. In an analysis of DOR, however, the cumulative duration of treatment with prior anti–PD-1/PD-L1 therapy was associated with DOR. Those who had a lower treatment duration on prior immunotherapy (less than 5.06 months), had a better duration of response to lifileucel (HR, 0.218; 95% CI, 0.056-0.854), which, Larkin said, was suggestive of statistical significance.

Upon multivariable analysis, baseline lactate dehydrogenase (LDH) levels and cumulative duration on prior anti–PD-1/PD-L1 therapy were both identified as being independent predictors of DOR to lifileucel. For baseline LDH below or at the upper limit of normal (ULN) compared to LDH above the ULN, the hazard ratio was 0.201 (95% CI, 0.040-0.996; 

= .049). With prior anti–PD-1/PD-L1 treatment, for each 3-month decrease in exposure, the hazard ratio was 0.715 (95% CI, 0.518-0.987) and 0.511 (95% CI, 0.268-0.974) with every 6-month decrease (

= .041). “This means that for each 6-month decrease in exposure to prior anti–PD-1/PD-L1 therapy, the median duration of response to lifileucel will be nearly doubled,” Larkin explained.

The mean number of tumor-infiltrating lymphocyte (TIL) cells infused was 27.3 x 109. Sufficient TILs were manufactured regardless of the tumor resection site, Larkin noted.

No correlation was found with tumor shrinkage based on total cell dose or CD4/CD8 TIL ratio, tumor reductions were seen across all ranges.

Treatment-emergent adverse events (TEAEs) were reported in all patients treated with lifileucel; grade 3/4 events were observed in 97.0%, but only 2 events were grade 5. The most common grade 3/4 TEAEs were thrombocytopenia (81.8%), anemia (56.1%), febrile neutropenia (54.5%), and neutropenia (39.4%).

“The adverse event profile was consistent with the underlying advanced disease and the safety profile of the conditioning and IL-2 regimens,” Larkin said. “The decreasing frequency of AEs over time is reflective of the potential benefit of a one-time treatment with lifileucel and no new safety risks were identified for lifileucel during long-term follow-up.”

C-144-01 is a multicenter, open-label, multi-cohort phase 2 study exploring the safety and efficacy of TIL therapy lifileucel in adult patients with advanced melanoma. The study enrolled patients with unresectable or metastatic melanoma who had been treated with at least 1 prior systemic therapy, including an anti–PD-1 therapy and if 

V600–mutant, BRAF/MEK inhibitors. Patients were required to have radiographic confirmation of progression, at least 1 resectable tumor lesion for TIL generation and at least one target lesion for response assessment, and an ECOG performance status of 0 to 1.

Patients were enrolled into 4 cohorts. Cohort 1 looked at patients treated with non-cryopreserved TIL product, generation 1; cohort 2 looked at patients treated with cryopreserved second-generation TIL product, and the pivotal cohort 4 looked at patients treated with cryopreserved second-generation TIL product. Cohort 3, which is looking at re-treatment with TIL therapy in 10 patients, is still enrolling. Larkin’s ASCO presentation focused on the patients in the second cohort.

These patients were predominantly male (59%) and had an ECOG score of 0 (56%). The median age was 55 years (range, 20-79). About a quarter of patients (26%) had 

V600E or V600K mutations and 68% were wild-type; positive PD-L1 expression (tumor proportion score ≥5%) was observed in 35%. LDH levels were above the ULN in 59% of patients. The mean number of lesions was 6, representing a high tumor burden. Liver and/or brain metastases were also reported in 42% of patients at baseline.

The mean number of prior therapies was 3.3 (range, 1-9). Ninety-nine percent of patients had progression on anti–PD-1/PD-L1 therapy and 77% had progressive disease on anti–CTLA-4.

In the trial, tissue was procured and shipped to a central facility for TIL generation with a processing time of 22 days. Patients were then given non-myeloablative lymphodepleting chemotherapy of cyclophosphamide followed by fludarabine. Lifileucel was then infused as a one-time treatment, followed by interleukin-2 administration of up to 6 doses before the patient could be discharged.

Larkin J, Sarnaik A, Chesney JA, et al. Lifileucel (LN-144), a cryopreserved autologous tumor infiltrating lymphocyte (TIL) therapy in patients with advanced melanoma: Evaluation of impact of prior anti-PD-1 therapy. 

2021;39(suppl 15):9505. doi:10.1200/JCO.2021.39.15_suppl.9505

Chesney JA, Larkin JMG, Kirkwood JM, et al. Lifileucel (LN-144), a cryopreserved autologous tumor infiltrating lymphocyte (TIL) therapy in patients with advanced (unresectable or metastatic) melanoma: durable duration of response at 28 month follow up. Presented at: 2021 American Association for Cancer Research Annual Meeting; April 10-15, 2021; Virtual. Abstract CT008.

Sarnaik A, Khushalani NI, Chesney JA, et al. Long-term follow up of lifileucel (LN-144) cryopreserved autologous tumor infiltrating lymphocyte therapy in patients with advanced melanoma progressed on multiple prior therapies. 

 2020;38(suppl 15):10006. doi:10.1200/JCO.2020.38.15_suppl.10006

Further follow up of lifileucel in patients with melanoma showed potentially follow progression on anti—PD-1 therapy. 

Lisa Astor | Authors

Articles

Adjuvant Targeted Therapy Proves Beneficial in Resected Stage III BRAF-Mutant Melanoma

Naratuximab Emtansine With Rituximab Leads to Durable Responses in R/R DLBCL

Belzutifan Shows Strong Responses in RCC and Other VHL-Associated Lesions

Maximized Benefit of Lifileucel in Melanoma Potentially Seen Following Anti–PD-1 Progression