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ASCO 2023 | News | Updates | Insights | iPharmaCenter

Updated: Jun 9, 2023

Kite presented findings from the largest real-world analysis of Tecartus (brexucabtagene autoleucel) in relapsed or refractory mantle cell lymphoma (R/R MCL) patients. The study demonstrates consistently high complete response (CR) and overall response rates (ORR) for Tecartus therapy, regardless of the type of prior treatment received.

The analysis included prospective data from 380 patients registered in the Center for International Blood and Marrow Transplant Research (CIBMTR) observational database. The patients had a median of four lines of prior therapy, with 87% previously exposed to Bruton's tyrosine kinase inhibitors (BTKi), 56% receiving bendamustine, and 30% undergoing autologous hematopoietic cell transplant (autoHCT).

Post median follow-up of 12 months, the overall response rate of 90% is similar to the results from the ZUMA-2 trial. The analysis also revealed a high complete response rate of 78% in patients who received Tecartus.

At 12 months, the duration of response (DOR), progression-free survival (PFS), and overall survival (OS) rates were 64%, 61%, and 74%, respectively.

Janssen presented positive findings from an interim analysis of Cohort 1 in the Phase 3 THOR study. The study compared the effectiveness of Balversa (erdafitinib) to chemotherapy in patients with metastatic or unresectable urothelial carcinoma (UC) who had specific gene alterations in the fibroblast growth factor receptor (FGFR) and had previously received treatment with an anti-programmed death ligand 1 (PD-[L]1) agent, Keytruda.

The THOR study is a Phase 3 randomized, open-label trial demonstrating the efficacy of Balversa in patients with urothelial carcinoma. It consists of two cohorts based on the type of prior therapy received. Cohort 1 included patients who had received prior treatment with an anti-PD-(L)1 agent, while Cohort 2 included patients who had received previous therapy without an anti-PD-(L)1 agent. In Cohort 1, patients were administered either Balversa or chemotherapy, while patients in Cohort 2 were randomized to receive either Balversa or pembrolizumab.

The study included overall survival (OS) as the primary endpoint, and the results showed that Balversa reduced the risk of death by 36 percent, meeting the study's predefined criteria for superiority. The overall survival with Balversa was 12.1 months, compared to 7.8 months for those who received chemotherapy. Additionally, Balversa demonstrated improvement in median progression-free survival (PFS) with 5.6 months compared to 2.7 months for chemotherapy. The objective response rate (ORR) was also higher, with Balversa at 45.6 percent compared to 11.5 percent for chemotherapy.

The safety profile of Balversa observed in the THOR study was consistent with its known safety profile in metastatic urothelial carcinoma.

Gilead Sciences has announced the long-term overall survival (OS) data from the Phase 3 TROPiCS-02 study, which evaluated the effectiveness of Trodelvy (sacituzumab govitecan) compared to comparator chemotherapy in patients with HR+/HER2- metastatic breast cancer. The trail recruited patients who had previously received endocrine-based therapies and at least two chemotherapies.

In this analysis, Trodelvy demonstrated a durable and clinically significant improvement in median overall survival compared to the comparator chemotherapy. Patients treated with Trodelvy had a median OS of 14.5 months, whereas those receiving comparator chemotherapy had a median OS of 11.2 months.

The progression-free survival rates were consistently higher for Trodelvy at landmark milestones of 6, 12, and 18 months. PFS versus chemotherapy at

  • Six months - 45.6% versus 29.4%

  • 12 months - 21.7% vs. 8.4%

  • 18 months - 14.4% vs. 4.7%

No new adverse events were observed compared to previous studies.

Moderna and Merck have released promising results from the Phase 2b KEYNOTE-942/mRNA-4157-P201 study. The clinical trial evaluated mRNA-4157 (V940), an investigational individualized neoantigen therapy (INT), in combination with Merck's anti-PD-1 therapy Keytruda, for patients with resected high-risk melanoma (stage III/IV).

The study's key secondary endpoint, distant metastasis-free survival (DMFS), showed significant and clinically meaningful improvements when mRNA-4157 (V940) was used in combination with Keytruda compared to Keytruda alone. The risk of distant metastasis or death was reduced by 65% in the adjuvant treatment group receiving mRNA-4157 (V940) and Keytruda. DMFS measures the time from the first dose of Keytruda until the first occurrence of distant recurrence or death from any cause.

These positive results have led to the granting of Breakthrough Therapy Designation by the Food and Drug Administration and the Priority Medicines (PRIME) scheme by the European Medicines Agency for mRNA-4157 (V940) in combination with Keytruda as an adjuvant treatment for patients with high-risk melanoma following complete resection.

Adverse events reported during the study were consistent with those observed in a previous Phase 1 clinical trial of mRNA-4157 (V940).

Based on the encouraging findings, Moderna and Merck have plans to initiate a Phase 3 study.

Janssen has presented long-term data from the CHRYSALIS study, indicating the effectiveness of Rybrevant (amivantamab) and lazertinib combination therapy as a first-line treatment for treatment-naïve patients with EGFR-mutated non-small cell lung cancer (NSCLC).

The study included patients with NSCLC who had EGFR exon 19 deletion or L858R mutation. After a median follow-up of 33.6 months, the median progression-free survival (PFS) was not reached, demonstrating favorable outcomes. The estimated PFS rates at one, two, and three years were 85%, 65%, and 51%, respectively.

The adverse event profile was consistent with the established safety profile.

Gilead and Arcus Biosciences announced positive findings from the ongoing ARC-7 study, evaluating the effectiveness of domvanalimab in patients with metastatic non-small cell lung cancer (NSCLC). The study focuses on individuals with high levels of PD-L1 (tumor proportion score ≥50%), excluding those with EGFR or ALK mutations.

ARC-7 is a Phase 2, randomized, open-label trial comparing three different treatment combinations -

  • zimberelimab monotherapy

  • omvanalimab plus zimberelimab

  • etrumadenant, domvanalimab, zimberelimab triple therapy

The median progression-free survival was

  • zimberelimab monotherapy: 5.4 months

  • omvanalimab plus zimberelimab: 9.3 months

  • etrumadenant, domvanalimab, zimberelimab triple therapy: 9.9 months

The objective response rate was

  • zimberelimab monotherapy: 15%

  • omvanalimab plus zimberelimab: 20%

  • etrumadenant, domvanalimab, zimberelimab triple therapy: 22%

Gilead stated that domvanalimab containing regimens were well tolerated.

Merck and the Canadian Cancer Trials Group (CCTG) have announced the results of the Phase 3 CCTG IND.227/KEYNOTE-483 trial, which evaluated the effectiveness of Keytruda, in combination with chemotherapy, as the first-line treatment for patients with unresectable advanced pleural mesothelioma.

The trial demonstrated that Keytruda plus chemotherapy significantly improved overall survival (OS) compared to chemotherapy alone, reducing the risk of death by 21%. The median OS for the Keytruda plus chemotherapy group was 17.3 months, compared to 16.1 months for the chemotherapy-alone group.

There was a significant improvement in progression-free survival (PFS) and objective response rate (ORR) with Keytruda plus chemotherapy compared to chemotherapy alone. The ORR was 62% in the Keytruda arm versus 38% in patients on chemotherapy.

The safety profile of KEYTRUDA plus chemotherapy was consistent with previous studies, with manageable adverse events reported.

Janssen presented findings from the MonumenTAL-1 study, showcasing the longer-term follow-up data of talquetamab, an investigational bispecific antibody, in patients with relapsed or refractory multiple myeloma (RRMM).

In the MonumenTAL-1 study, patients (n=339) received subcutaneous talquetamab at either 0.8 mg/kg biweekly (Q2W) or 0.4 mg/kg weekly (QW) with step-up doses. The overall response rates (ORR) were consistent across both dosing regimens. With a median follow-up of 12.7 months, the 0.8 mg/kg Q2W dose achieved an ORR of 71.7%, with 60.7% achieving a very good partial response (VGPR) or better, and 29.7% achieving a stringent complete response. Similarly, with a median follow-up of 18.8 months, the 0.4 mg/kg QW dose had an ORR of 74.1%, with 59.4% achieving VGPR or better, 9.8% achieving CR, and 23.8% achieving a stringent CR. In a separate cohort of patients previously treated with T-cell redirection therapy, the ORR was 64.7%, with 54.9% achieving VGPR or better.

The responses to talquetamab were durable, with a median duration of response (DOR) not yet reached for patients receiving the Q2W dose and a median DOR of 9.5 months for those on the QW dose. The 12-month overall survival (OS) rates were 77.4%, 76.4%, and 62.9% for the 0.8 mg/kg Q2W dose, 0.4 mg/kg QW dose, and prior T-cell redirection cohorts, respectively. The 12-month progression-free survival (PFS) rates were 54.4%, 34.9%, and 38.1% for the same cohorts, respectively.

The study also demonstrated a low discontinuation rate due to adverse events.

Novartis has announced positive findings from the pivotal Phase III NATALEE trial. The data revealed that Kisqali (ribociclib), in combination with endocrine therapy (ET), significantly reduced the risk of cancer recurrence by 25.2% in patients with stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer, compared to ET alone.

The study also showed consistent and clinically meaningful benefits in invasive disease-free survival (iDFS) across various patient subgroups.

Kisqali demonstrated consistent efficacy in all secondary endpoints, including distant disease-free survival (DDFS) with a 26% risk reduction, recurrence-free survival (RFS) with a 28% risk reduction, and a favorable trend towards improved overall survival (OS).

Furthermore, the safety profile of Kisqali at a dosage of 400 mg was favorable, with low rates of symptomatic adverse events (AEs) and minimal need for dose adjustments over three years. The most frequently reported AEs of particular interest (grade 3 or higher) were neutropenia (43.8%) and liver-related AEs, such as elevated transaminases (8.3%). Grade 3 or higher incidences of QT interval prolongation and diarrhea were rare, occurring in only 1.0% and 0.6% of patients, respectively.

Based on these results, Novartis intends to seek indication expansion from the regulatory agencies in the US and Europe by the end of this year.

Merck has announced positive results from the pivotal Phase 3 KEYNOTE-671 trial, which investigated the use of Keytruda as a perioperative treatment regimen for patients with resectable stage II, IIIA, or IIIB non-small cell lung cancer (NSCLC).

During the trial, patients received a combination of neoadjuvant Keytruda plus chemotherapy followed by adjuvant Keytruda after surgery. Following a median follow-up of 25.2 months, the neoadjuvant Keytruda regimen demonstrated a significant improvement in event-free survival (EFS), reducing the risk of disease recurrence, progression, or death by 42% compared to the neoadjuvant placebo plus chemotherapy regimen. The median EFS for patients receiving the Keytruda-based regimen was not reached, while it was 17 months for patients receiving chemotherapy alone.

The trial is still ongoing to allow for further follow-up and assessment of the primary endpoint, overall survival (OS). Encouragingly, there was a positive trend in OS for the Keytruda regimen compared to pre-operative chemotherapy.

The adverse events observed in the trial was consistent with the known adverse events of Keytruda.

Regeneron presented data from Phase 2 expansion dose cohorts, highlighting the potential of linvoseltamab in heavily pre-treated patients with relapsed/refractory multiple myeloma.

The updated data includes results from the 50 mg (n=104) and 200 mg (n=117) cohorts of the Phase 1/2 trial. The primary endpoint of the study was the objective response rate (ORR), and secondary endpoints included ORR and other efficacy measures. After a median follow-up of 6 months, patients receiving the recommended 200 mg dose showed promising results:

  • The objective response rate was 71%.

  • 59% of patients achieved a very good partial response (VGPR) or better.

  • 30% of patients achieved a complete response.

  • The median duration of response: <1 month.

  • The median progression-free survival was not reached.

The 200 mg cohort consistently demonstrated strong efficacy in terms of ORR across various subgroups, including high-risk patients such as those aged 75 years or older.

Among patients administered the 200 mg dose of linvoseltamab, Grade ≥3 adverse events were observed in 79% of patients. Other common adverse events included cytokine release syndrome, neutropenia, cough, fatigue, and diarrhea.

Bristol Myers Squibb presented data from the Phase 3 CheckMate -9LA trial, showing promising long-term survival outcomes in patients with metastatic non-small cell lung cancer (NSCLC) treated with Opdivo (nivolumab) plus Yervoy (ipilimumab) in combination with chemotherapy.

The study, which spanned four years and included previously untreated patients, demonstrated sustained clinical benefits compared to chemotherapy alone. With a minimum follow-up period of 47.9 months, the dual immunotherapy-based combination of Opdivo plus Yervoy with two cycles of chemotherapy continued to enhance overall survival (OS), which was the trial's primary endpoint. At the four-year mark, 21% of patients treated with the combination therapy were still alive, compared to 16% of patients treated with chemotherapy alone.

The extended follow-up analysis also confirmed the clinically significant efficacy benefit of Opdivo plus Yervoy with two cycles of chemotherapy across secondary endpoints and specific patient subgroups. Patients with tumor PD-L1 expression levels below 1% experienced an OS rate of 23% with the immunotherapy combination, as opposed to 13% with chemotherapy alone, representing a 34% reduction in the risk of death. Among patients with squamous histology, the dual immunotherapy combination doubled (20%) the number of survivors at four years compared to chemotherapy alone (10%). The risk of death was reduced by 36% with the combination therapy compared to chemotherapy alone in this subgroup.

Notably, no new safety concerns emerged with the extended follow-up of the CheckMate -9LA trial in Opdivo Yerboy combination.

Merck and Eisai have released new data from the Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial, demonstrating the long-term benefits of Keytruda plus Lenvima for treating advanced renal cell carcinoma (RCC). After four years of follow-up, the combination therapy significantly improved overall survival (OS) compared to sunitinib.

The trial analysis revealed a 21% reduction in the risk of death with Keytruda plus Lenvima. The estimated OS rates at 24 and 36 months were 80.4% and 66.4% for the combination therapy, respectively, compared to 69.6% and 60.2% for sunitinib. These results align with the superior outcomes observed in the primary analysis of the CLEAR/KEYNOTE-581 trial, confirming the sustained and clinically meaningful OS benefit of Keytruda plus Lenvima.

Also, the risk of disease progression or death was reduced by 53% in the combination compared to sunitinib. The median progression-free survival (PFS) was 23.9 months for Keytruda plus Lenvima and 9.2 months for sunitinib. The objective response rate (ORR) was 71.3% for the combination therapy, with a complete response (CR) rate of 18.3%, while sunitinib achieved an ORR of 36.7% with a CR rate of 4.8%.

The safety analysis of the final OS results showed no new safety concerns, and the profile remained consistent with the primary analysis. Grade ≥3 treatment-related adverse events (TRAE) occurred in 74.1% of patients receiving Keytruda plus Lenvima, compared to 60.3% of patients receiving sunitinib.

Bristol Myers Squibb has revealed the primary analysis results from the pivotal TRANSCEND CLL 004 study, which evaluated the efficacy of Breyanzi (lisocabtagene maraleucel) in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

After a median follow-up of 21.1 months, Breyanzi exhibited a complete response (CR) rate of 18.4% in the primary efficacy analysis set, with no disease progression or deaths observed among patients who achieved a CR.

The TRANSCEND CLL 004 trial represents a CAR T cell therapy treatment for relapsed or refractory CLL after progression on a BTK inhibitor (BTKi) and BCL2 inhibitor (BCL2i). The trial's results, consistent across the patient population, showed high rates of undetectable minimal residual disease (uMRD) in the blood (63.3%) and bone marrow (59.2%), indicating a reduction in disease burden and an increase in progression-free survival. After median duration of 35.3 months, the overall response rate was 42.9%.

Breyanzi exhibited a manageable safety profile in all treated patients, including heavily pretreated individuals.

BMS stated that the data showcase the significant clinical benefit and promise of Breyanzi as the first and only CAR T cell therapy delivering profound and durable efficacy in relapsed or refractory CLL and SLL.


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