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The Latest Research in Biliary Tract Cancers Presented at ASCO GI 2021

March 2021, Vol 2, No 1

At the CCA Summit held during the 2021 ASCO Gastrointestinal (GI) Cancers Symposium, Rachna T. Shroff, MD, MS, Chief, Section of GI Medical Oncology, University of Arizona Cancer Center, Tucson, discussed 15 clinical trials that were presented at the ASCO GI Cancers Symposium on cholangiocarcinoma (CCA) and hepatobiliary diseases. She highlighted key advances related to chemotherapy, targeted therapies, and biomarkers in the management of biliary tract cancers, including CCA.

In This Article

Efficacy and Safety of Nab-Paclitaxel Combined with Gemcitabine and Cisplatin in Patients with Advanced Biliary Tract Cancers

Cheon and colleagues looked at the combination of nab-paclitaxel plus gemcitabine and cisplatin in patients with advanced biliary tract cancers, based on information related to this combination in a previously published phase 2 clinical trial.

The current analysis was a retrospective analysis of data from 3 different institutions in Korea and included 104 patients who had received the triplet regimen of nab-paclitaxel plus gemcitabine and cisplatin for the treatment of advanced biliary tract cancers. A large portion of the patient population (40.4%) had intrahepatic cholangiocarcinoma, and more than three-fourths (78.8%) of the patients had metastatic disease.

More than half (57.7%) of the patients began treatment with the triplet regimen, 15.4% received the triplet regimen after lack of response to gemcitabine and cisplatin, with or without an investigational drug, and 26.9% of patients received nab-paclitaxel plus gemcitabine and cisplatin before their disease progressed.

The overall objective response rate (ORR) in the entire patient population was 30.8%. The ORR in the cohort that added nab-paclitaxel to treatment before disease progression was 39.3%. Among those whose disease did not respond to gemcitabine and cisplatin therapy, the ORR dropped to 6.3%.

The median overall survival and progression-free survival were not reached, although the median follow-up duration was only 3.3 months. The most common grade 3 or 4 adverse events consisted primarily of hematologic events, including neutropenia, anemia, and thrombocytopenia.

A total of 22 patients in the study had locally advanced biliary tract cancers, and in 5 (22.7%) of them, the disease was converted to resectable disease after receiving the triple regimen, and they underwent surgery.

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Effect of FGFR2 Alterations on Survival in Patients Receiving Systemic Chemotherapy for Intrahepatic Cholangiocarcinoma

In this retrospective analysis, Abou-Alfa and colleagues evaluated progression-free survival (PFS) and overall survival (OS) in patients with intrahepatic cholangiocarcinoma (CCA) and FGFR2 fusion or wild-type CCA who received systemic chemotherapy. Of the 132 patients included in this study, only 15 patients had FGFR2-positive disease.

In patients who received first-line chemotherapy, the median PFS was 7.1 months for all the patients, 6.2 months for patients with FGFR2 fusion, and 7.2 months for patients with wild-type CCA.

The median PFS among patients receiving second-line chemotherapy was 5.6 months in patients with FGFR2 fusion and 3.7 months in patients with wild-type disease. The median OS was 31.3 months in the patients with FGFR2 fusion compared with 21.8 months in patients with wild-type CCA.

Although this study’s small sample size is a limiting factor, Dr Shroff said, these results may “suggest a little bit about biology in terms of the FGFR2 fusion–positive patients who are seemingly doing better in terms of OS and second-line and subsequent therapies, which suggests that perhaps these [results] are more related to the natural history of FGFR2 fusion–positive patients, as we’ve seen in other previously reported data.”

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Safety and Efficacy of INCB001158, an Arginase Inhibitor, plus Chemotherapy in Advanced Biliary Tract Cancers

In this phase 2 study, Javle and colleagues used a Simon 2-stage design to evaluate the objective response rate (ORR) in patients with biliary tract cancer, using the oral, 100-mg twice-daily dose of the arginase inhibitor INCB001158. This dose was identified in a phase 1 dose-escalation study of the arginase inhibitor to be used in combination with gemcitabine and cisplatin standard chemotherapy.

At the time of data cutoff in this phase 2 study, 33 patients with biliary tract cancers had received treatment with gemcitabine and cisplatin plus INCB001158.

Stable disease was seen in 42% of the patients who received the combination of this novel arginase inhibitor plus standard chemotherapy. The median duration of response was 5.8 months, disease control rate was 67%, and the median progression-free survival (PFS) was 8.5 months.

Treatment-related adverse events were seen in 88% of the patients and 73% were believed to be directly related to the arginase inhibitor. Treatment interruption because of side effects was reported in 30% of patients. No significant immune-related or additive chemotherapy-associated adverse events were reported. The ORR in this population was 24%, which was based on confirmed response from the investigator assessment.

Although this new drug was safe and did not add significant adverse events to standard chemotherapy, Dr Shroff noted that questions remain regarding its efficacy, although this may stem from the small sample size, and the similarity in the response rate and median PFS to those seen with chemotherapy alone.

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Second-Line Chemotherapy in Elderly Patients with Advanced Biliary Tract Cancer

Using institutional registries across 3 different medical centers, Rizzo and colleagues retrospectively identified a total of 190 patients with advanced biliary tract cancer who received second-line therapy, 52 of whom were aged ≥70 years. Nearly 50% of the patients had intrahepatic cholangiocarcinoma. The most common second-line therapies included single-agent capecitabine, single-agent gemcitabine, and the combination of these 2 chemotherapies.

The disease control rate with the second-line therapy was 28.8% in the older patients and 29.7% in the younger patients, with no significant differences in the median overall survival and progression-free survival. Grade 3 or 4 treatment-related adverse events were much more common in the older than the younger patient population (48.5% vs 8.2%, respectively).

Several prognostic factors were identified, including absolute lymphocyte count and albumin levels, that were independently associated with the worst prognosis.

Dr Shroff commented that second-line therapy can produce good outcomes in this patient population, but the efficacy should be balanced against the higher incidence of grade 3 or 4 adverse events that were seen in older patients.

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Infigratinib, an FGFR-Selective Tyrosine Kinase Inhibitor, in Patients with Advanced Cholangiocarcinoma Harboring FGFR2 Fusions or Rearrangements

In this study, Javle and colleagues analyzed the results of cohort 1 of a phase 2 study of infigratinib in patients with advanced cholangiocarcinoma (CCA); this cohort included patients who had not received infigratinib before the phase 2 study. The primary end points were the objective response rate (ORR), by independent central review, and the duration of response. The secondary end points included progression-free survival (PFS) and disease control rate.

This new analysis included 108 patients with advanced CCA who received infigratinib for the first time during this study, 77% of whom had FGFR2 fusions or rearrangements. Of the 108 patients, 54% had previously received ≥2 lines of therapy, and the other patients had received 1 line of therapy. The ORR in the entire cohort was 23.1%, including 1 complete response and 24 partial responses.

The median duration of response was 5 months. Among patients who responded to treatment, 8 had a duration of response of ≥6 months. The median PFS in this cohort was 7.3 months.

Among patients who had previously received only 1 line of therapy and were receiving infigratinib in the second-line setting, the ORR was 34%. Among patients who received infigratinib in the third-line or later setting, the ORR dropped to 13.8%.

The most common treatment-emergent adverse events were those often associated with FGFR inhibitors, including hyperphosphatemia, eye disorders, and stomatitis.

“We are learning more and more about the adverse events that are associated with FGFR-directed therapies and, thus, being more proactive and aggressive in their management,” Dr Shroff said.

“We have learned over time how to keep patients on this drug, and to keep them compliant, which further enhances its potential efficacy,” Dr Shroff emphasized.

In December 2020, the FDA accepted the New Drug Application for infigratinib for biliary tract cancer with FGFR1-3 mutations.

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ClarIDHy: Ivosidenib versus Placebo in Patients with Cholangiocarcinoma and IDH1 Mutation

In the global, phase 3, randomized, double-blind study, Zhu and colleagues randomized 187 patients with cholangiocarcinoma (CCA) and IDH1 mutation to ivosidenib (Tibsovo) and 61 to placebo. Patients could cross over from the placebo arm to the ivosidenib arm at disease progression if they met eligibility criteria.

In all, 70% of patients crossed over from placebo to ivosidenib. Nearly half (47%) of the patients in the study had received 2 previous lines of therapy. The overall survival (OS) data, which were mature at the time of this presentation, was 79% in the ivosidenib arm.

The median OS was 10.3 months with ivosidenib and 7.5 months with placebo (hazard ratio [HR], 0.79; P = .93). The adjusted median OS in the placebo arm was 5.1 months based on analysis using the rank-preserving structural failure time model (HR, 0.49; P <.0001).

All-grade treatment-emergent adverse events in the ivosidenib arm included nausea, diarrhea, and fatigue. The rate of grade 3 or 4 adverse events was 50% with ivosidenib and 37% with placebo. Only 7% of patients in the ivosidenib arm had adverse events that led to treatment discontinuation.

Dr Shroff agreed with the investigators’ conclusion that there was a clinical benefit to using ivosidenib in patients with IDH1-positive CCA.

“For those of us who have used this drug, we know it is very well-tolerated. Especially after months of IV [intravenous] chemotherapy, it is a really nice change for our patients. They’re able to improve in terms of quality of life,” she said.

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Pemigatinib’s Impact on Quality of Life in Patients with FGFR2-Driven Cholangiocarcinoma

Valle and colleagues assessed the impact of pemigatinib (Pemazyre) on the quality of life in patients with cholangiocarcinoma (CCA) and FGFR2 mutation. Patients’ quality of life was assessed by best overall response per RECIST using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and the biliary tract cancer–specific EORTC QLQ-BIL21 questionnaires. Of the 107 patients with CCA and FGFR2 mutation in the study, 100 (93%) were evaluable for quality of life.

Patients were assessed from baseline to week 16 in terms of overall health status. The researchers found that emotional functioning was stable, and the overall health status was maintained in patients who had a complete or partial response to treatment and in patients with stable disease. However, these attributes worsened in patients with progressive disease.

Patients in all subgroups showed some decline in role and social functioning. Patients with a response to treatment or with stable disease also had decreases in pain and anxiety, as measured by EORTC QLQ-BIL21. All subgroups showed increases in treatment-related side effects.

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Zanidatamab in Patients with HER2-Positive Biliary Tract Cancers

HER2 overexpression or amplification is seen in 5% to 19% of biliary tract cancers and is probably more pronounced in patients with gallbladder cancer or with extrahepatic cholangiocarcinoma (CCA). Zanidatamab is a bispecific HER2-targeting antibody that has shown good single-agent activity in a variety of HER2-overexpressing cancers.

In this study, Meric-Bernstam and colleagues investigated an expansion cohort of a phase 1 clinical trial. The primary objective was assessment of the safety and tolerability of zanidatamab; the secondary objectives included evaluation of antitumor activity.

The study cohort included patients with biliary tract cancer and centrally confirmed HER2 overexpression, as defined by immunohistochemistry (IHC)3-positive, IHC2-positive, or fluorescence in situ hybridization–positive status. This was a heavily pretreated patient population, with a median of 2.5 previous therapies per patient, including 5 patients who had received previous HER2-targeting therapy with trastuzumab (Herceptin).

Zanidatamab was administered every 2 weeks. At data cutoff, 20 patients with biliary tract cancers (ie, 11 patients with gallbladder cancer, 5 with intrahepatic CCA, and 4 with extrahepatic CCA) received treatment with zanidatamab.

In all, 70% of patients had grade 1 or 2 zanidatamab-related adverse events. The most common adverse events were diarrhea and infusion-related reactions. The confirmed objective response rate among the 17 patients who were evaluable for response was 47%, with a disease control rate of 65%, and median duration of response of 6.6 months.

In November 2020, the FDA granted zanidatamab a breakthrough therapy designation for previously treated patients with HER2-amplified biliary tract cancer.

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Silmitasertib plus Gemcitabine and Cisplatin as First-Line Treatment for Patients with Locally Advanced or Metastatic Cholangiocarcinoma

This multicenter, open-label study by Borad and colleagues included 2 phases: phase 1b included dose-escalation, expansion, and exploratory cohorts of silmitasertib, an oral casein kinase 2 inhibitor. In the phase 2 portion of the study, patients received silmitasertib plus gemcitabine and cisplatin on days 1 and 8 of a 21-day cycle. Treatment response was measured by RECIST.

A total of 87 patients were enrolled in the study (ie, 50 patients in phase 1b and 37 in phase 2), 55 of whom were evaluable for efficacy. The median progression-free survival was 11.1 months, the median overall survival was 17.4 months, and the overall response rate was 32.1%.

The most common treatment-emergent adverse events were diarrhea, nausea, vomiting, fatigue, and anemia. The most common grade 3 or 4 adverse events were diarrhea, neutropenia, nausea, anemia, and thrombocytopenia. Treatment-emergent adverse events led to treatment discontinuation in 12.6% of patients.

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Neratinib for Advanced Biliary Tract Cancers with HER2 Mutation: The SUMMIT Basket Trial

The SUMMIT study by Harding and colleagues was a large, phase 2 basket study that tested the use of neratinib (Nerlynx) monotherapy in patients with somatic HER2-positive solid tumors, including some patients with biliary tract cancer. Approximately 2% to 5% of patients with biliary tract cancers have somatic HER2 mutations.

Loperamide prophylaxis was mandated by protocol, because of neratinib’s association with diarrhea. The efficacy end points included objective response rate (ORR) and progression-free survival (PFS).

In this study, Harding and colleagues enrolled 25 patients with biliary tract cancers and HER2 mutation, including 40% with gallbladder cancer; 24% intrahepatic bile duct cancer; 20% extrahepatic bile duct cancer; and 16% ampulla of Vater. Most patients had received ≥2 previous systemic therapies.

Nearly 50% of the patients had the S310F/Y variant of the HER2 mutation. Treatment with neratinib resulted in a confirmed ORR of 12% in the 25 evaluable patients, with a clinical benefit rate of 20%, including 3 confirmed partial responses, and 2 patients had stable disease at 16 weeks. The median PFS was 2.8 months, and the median overall survival was 5.4 months. The most common adverse events of any grade were diarrhea and vomiting. Diarrhea was also the most common grade 3 event. Overall, 4 (16%) patients required a dose reduction of neratinib.

“In patients who have these rare somatic HER2 mutations, some of the numbers that we’re seeing in terms of objective response rate and median progression-free survival are probably similar to those that we see in a refractory cholangiocarcinoma population,” Dr Shroff said.

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Targeted Therapies for Cholangiocarcinoma: Assessment of Practice Patterns of US Oncologists

In this study, Parikh and colleagues used the responses to 25 multiple-choice questions in clinical practice assessment designed to measure the knowledge, competence, confidence, and attitudes of oncologists about molecular testing, available clinical evidence, and the relevance of using targeted therapies in patients with unresectable cholangiocarcinoma. More than 1000 responders, including 758 physicians, completed this activity.

The majority of the 104 participating oncologists practiced in the community setting and managed patients with a variety of cancers, not just gastrointestinal cancers. The oncologists demonstrated gaps in knowledge related to the use of next-generation sequencing (NGS), biomarker testing, and targeted therapies: 21% did not use them; 32% used them only at the time of disease progression; 35% did not realize that not all panels detect FGFR2 fusions; 20% did not test for biomarkers; 29% tested for IDH mutations, and 56% tested for FGFR alterations.

In all, 45% of respondents understood biomarker eligibility in the FIGHT202 and ClarIDHy trials for pemigatinib (Pemazyre); only 9% recognized the overall survival outcomes for pemigatinib; 30% understood some of the adverse events associated with pemigatinib. Overall, 51% recognized the progression-free survival end point with ivosidenib (Tibsovo) and 55% recognized the adverse events associated with it.

These results show the gaps in knowledge and confidence regarding NGS, biomarker testing, and the proper implementation of targeted therapies into clinical practice, Dr Scroff said.

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Infigratinib for Patients with Advanced or Metastatic Cholangiocarcinoma and FGFR Fusions or Other Alterations

This ongoing phase 2 study by Javle and colleagues is enrolling patients with advanced or metastatic cholangiocarcinoma and FGFR genetic alterations who have received previous therapy with gemcitabine. In this phase 2 study, all patients are receiving oral infigratinib. The patients are divided into 3 cohorts. Cohort 1 consists of patients with FGFR2 gene fusions or translocations. Cohort 2 includes patients with FGFR genetic alterations that are different from FGFG2 gene fusions. Cohort 3 comprises patients with FGFR2 gene fusions who have had previous treatment with a selective FGFR inhibitor other than infigratinib.

The primary end point in this study is the objective response rate. The planned total enrollment is 160 patients, with 120 patients planned for cohort 1 and 20 patients for each of the other 2 cohorts.

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Lenvatinib plus Pembrolizumab for Patients with Previously Treated Biliary Tract Cancers: The LEAP-005 Study

Villanueva and colleagues evaluated the results from the biliary tract cancers cohort of the phase 2 multicohort LEAP-005 study. In this open-label, nonrandomized study, all patients received lenvatinib (Lenvima), a multikinase inhibitor, and the PD-1 inhibitor pembrolizumab (Keytruda). The primary end point was objective response rate (ORR). The 31 patients enrolled into this nonrandomized cohort had all received 1 previous line of therapy.

Three (10%) patients had a partial response to this combination and 18 (58%) patients demonstrated stable disease. The ORR was 10%, and the disease control rate was 68%. The median duration of response was 5.3 months, the median progression-free survival was 6.1 months, and the median overall survival was 8.6 months. Treatment-related adverse events were seen in 97% of patients, including 48% grade 3 or 4.

There were no treatment-related deaths. The most common treatment-related adverse events were hypertension, dysphonia, diarrhea, fatigue, and nausea. Immune-mediated adverse events occurred in 45% of patients, and 1 patient had an infusion-related reaction.

“Obviously, this is a very hot combination, based on some of the additional data that have come out, for instance, in hepatocellular cancer,” Dr Shroff said. “I think a larger and more robust cohort will help us tease out its role in biliary tract cancers,” she suggested.

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Role of ctDNA in Predicting Recurrence Risk After Potentially Curative Resection of Biliary Tract or Pancreatic Cancers

Lamarca and colleagues used molecular profiling with circulating-tumor DNA (ctDNA) to evaluate 11 patients with pancreatico-biliary cancers who had undergone curative resection. In all, 8 patients had biliary cancers, including 4 extrahepatic cholangiocarcinoma (CCA); 2 ampullary cancers; 1 intrahepatic CCA; and 1 gallbladder cancer, and 3 patients had pancreatic cancer.

Most patients were pT2 (45.45%), pN0 (54.55%), and R0 (63.64%). Six patients were started with adjuvant therapy. At the median follow-up of just more than 11 months, 5 patients had relapsed disease, and 2 patients died.

The estimated median recurrence-free survival for the whole group was 11.43 months, with a median overall survival that was not reached. The presence of ctDNA was detected in 3 patients, which resulted in a trend toward disease relapse.

The mean maximum mutated allele frequency was 1.47 (2 in biliary cancer; 0.43 in pancreatic cancer). Variants of uncertain significance were identified in 72.73% of the samples.

Dr Shroff noted that this study “suggests the feasibility of following ctDNA and detecting ctDNA in cured and resected pancreaticobiliary malignancies. There’s definitely, I would say, hypothesis-generating data here that suggest that the presence of ctDNA after resection could be associated with an increased relapse risk.”

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Actionable Somatic Alterations in Advanced Cholangiocarcinoma Using Circulating-Tumor and Tissue-Based DNA Profiling

Kasi and colleagues looked at the comparative landscape of actionable somatic alterations in patients with advanced cholangiocarcinoma (CCA), using circulating-tumor DNA (ctDNA) and tissue-based DNA profiling.

Kasi and colleagues retrospectively analyzed 137 patients with advanced CCA, using the Tempus tissue and Tempus liquid–based platforms. Most (110) patients were tested once, and 27 patients had ≥2 tests. The total genomic results included 113 tissue-based next-generation sequencing results and 61 liquid-based next-generation sequencing results.

The findings included FGFR2 fusions (6.8%), IDH1/2 mutations (8.4%), BRAF mutations (2.5%), and a smattering of HER2, MET, BRCA1, BRCA2, and ATM mutations, among others.

The proportion of genomic aberrations found in the ctDNA liquid biopsy cohort was 33.1% compared with 23.2% in the tissue-based cohort. FGFR2 fusions were seen in 11.3% of the samples in the liquid ctDNA platform compared with 3.4% in the tissue biopsies.

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