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Prof. Dr. Mustafa Özdoğan · Medical Oncologist

Ivonescimab and Durvalumab: HARMONi-GI1 Trial Results

Ivonescimab and Durvalumab: HARMONi-GI1 Trial Results
In this article

On 25 October 2026, at Presidential Symposium II of ESMO 2026 in Madrid (LBA8), the results of the phase 3 HARMONi-GI1 trial were presented. It compares ivonescimab + gemcitabine–cisplatin with durvalumab + gemcitabine–cisplatin. In 682 previously untreated patients with advanced biliary tract cancer, median overall survival was 14.9 months versus 12.1 months (HR 0.75) and median progression-free survival was 8.4 months versus 5.8 months (HR 0.61). The result deserves attention. But the trial was run only in China, a single region; the overall survival data come from an interim analysis; the full paper has not been published; and ivonescimab is not approved for biliary tract cancer in any country. Grade ≥3 adverse events were also more frequent in the combination arm.

Who is this article for? People diagnosed with biliary tract cancer (cholangiocarcinoma or gallbladder cancer) and their relatives, health professionals who follow this disease, and anyone interested in reading a clinical trial. This article is not medical advice; no treatment decision should be made on the basis of this text.

This story arrived in two stages. On 25 August 2026, Akeso announced that the trial had met its primary endpoint (overall survival) and key secondary endpoints (PFS, response rate) at a prespecified interim analysis, but without a single number. The numbers were first presented on 25 October. In the meantime, on 21 October 2026, a separate US trial testing ivonescimab (EA2251) was announced; we cover it below.

Whose words are "new standard", "first" and "major breakthrough"? In stories like this, strong claims spread quickly; it helps to separate who said what.

  • "New standard of care" is attributed in OncLive to the presenter, Dr. Jian Zhou (Zhongshan Hospital, Shanghai); OncoDaily sums up the same result as a "potential new first-line standard-of-care option". This is not a regulatory decision; ivonescimab is not approved for biliary tract cancer in any country.
  • "The first phase 3 trial to show significantly better overall survival than durvalumab + chemotherapy" is the description of Zhou and of the trial sponsor, Akeso; Zhou limits it to "a Chinese population". We could not verify this claim independently.
  • "Major breakthrough" are the words of Michelle Xia, founder and CEO of Akeso; it is company language, not an independent assessment.
  • Sponsor and data: according to Summit's statement, all relevant data were generated, managed and analyzed exclusively by Akeso. Zhou's disclosures include research funding from many companies, among them Akeso-Sino, and advisory roles at AstraZeneca, MSD and Pfizer (per OncLive). The control-arm drug (durvalumab) belongs to AstraZeneca.

Background: first-line treatment in biliary tract cancer

Biliary tract cancer starts in the bile ducts inside the liver (intrahepatic cholangiocarcinoma), the bile ducts outside the liver (extrahepatic cholangiocarcinoma) or the gallbladder. In the advanced stage, the first-line standard is gemcitabine–cisplatin chemotherapy plus an immune checkpoint inhibitor: durvalumab on the TOPAZ-1 data, pembrolizumab on the KEYNOTE-966 data. We explained what pembrolizumab is in our article on Keytruda (pembrolizumab) (in Turkish). Molecular tests that look for targetable changes in a patient's tumor also matter in this picture; we described them in our article on next-generation sequencing (NGS) (in Turkish).

Three phase 3 trials in the first line
Trial Design and patients Main result Note
TOPAZ-1
(phase 3)
Randomized, double-blind, placebo-controlled; durvalumab + gemcitabine–cisplatin vs placebo + gemcitabine–cisplatin; previously untreated patients Median overall survival 12.9 vs 11.3 months, HR 0.76 (0.64–0.91); response rate 26.7% vs 18.7% Made the durvalumab combination the first-line standard; basis of the HARMONi-GI1 control arm
KEYNOTE-966
(phase 3)
1,069 patients; pembrolizumab + gemcitabine–cisplatin vs placebo + gemcitabine–cisplatin Median overall survival 12.7 vs 10.9 months, HR 0.83 (0.72–0.95) The pembrolizumab combination is also a standard option
HARMONi-GI1
(phase 3, China)
682 patients, double-blind; ivonescimab + gemcitabine–cisplatin vs durvalumab + gemcitabine–cisplatin Median overall survival 14.9 vs 12.1 months, HR 0.75 (0.61–0.92); median PFS 8.4 vs 5.8 months, HR 0.61 (0.51–0.72) Subject of this article; interim analysis

Caution when reading this table: the three trials cannot stand in for one another. The control arm of TOPAZ-1 and KEYNOTE-966 was chemotherapy alone (plus placebo), whereas the control arm of HARMONi-GI1 already contains immunotherapy. HARMONi-GI1 was also run only in China; the patient population, length of follow-up and region differ. So comparing the overall survival median of the durvalumab arm (12.1 months) with the 12.9 months of TOPAZ-1 and calling it "consistent" or "inconsistent" would not be a sound comparison; the HRs cannot be compared directly either.

What is ivonescimab?

Ivonescimab (AK112; SMT112 in Summit's licensed territories) is a bispecific antibody that binds PD-1 and the blood-vessel growth factor VEGF at the same time; it is given into a vein once every three weeks and was developed by Akeso. The idea: with a single molecule, hit the "brake" PD-1 on immune cells and the VEGF that helps a tumor build blood vessels. It is approved in China only for lung cancer (first approval in May 2024, according to Summit); it is not approved for any indication in the US or Europe. For biliary tract cancer, China's drug regulator NMPA granted the combination "breakthrough therapy" status in February 2026; the decision rests on a phase 1b/2 study presented at ASCO 2024 (response rate 63.6%, disease control rate 100%, median PFS 8.5 months, median overall survival 16.8 months). CancerNetwork additionally mentions "priority review in China"; we could not verify this in another source.

HARMONi-GI1 at a glance

Trial HARMONi-GI1 (NCT06591520; AK112-309) — randomized, double-blind, multicenter, single-region (China) phase 3
Presentation Zhou J et al. ESMO 2026, LBA8, Presidential Symposium II, 25 October 2026. We could not find any information on publication of the full paper
Sponsor Akeso (developer of ivonescimab); Summit Therapeutics is the drug's partner in its licensed territories and is not the sponsor of this trial
Patients 682 patients, randomized 1:1. Locally advanced or metastatic biliary tract cancer, unresectable at the outset or recurrent after curative treatment; no prior systemic therapy; ECOG 0-1
Arms Ivonescimab 20 mg/kg + gemcitabine 1000 mg/m² + cisplatin 25 mg/m² (n=340) vs durvalumab 1500 mg + the same chemotherapy (n=342); chemotherapy on days 1 and 8, every 3 weeks, up to 8 cycles; then blinded maintenance treatment
Primary endpoint Overall survival
Key secondary Progression-free survival (PFS) and objective response rate; tested in a prespecified hierarchy
Stratification Disease status (locally advanced / metastatic) and primary tumor location
Analysis Preplanned interim analysis; assessed by an independent data monitoring committee (IDMC). Median follow-up 14.3 months. The data cutoff date has not been published
Subsequent therapy 31.8% of patients in the combination arm and 45.9% in the durvalumab arm received subsequent anticancer treatment

Baseline patient characteristics (age, sex, disease status and so on) do not appear in the summaries available to us; so we cannot judge the balance between the arms. The number of centers has also not been published.

Results

14.9 vs 12.1 monthsMedian overall survival — HR 0.75 (0.61–0.92), one-sided p=0.0031
8.4 vs 5.8 monthsMedian PFS — HR 0.61 (0.51–0.72), one-sided p<0.0001
53.8% vs 32.5%Objective response rate
91.5% vs 77.8%Disease control rate

Median duration (months)

Colored bar — ivonescimab + chemotherapy, gray bar — durvalumab + chemotherapy.

Overall survival — ivonescimab
14.9 months
Overall survival — durvalumab
12.1 months
PFS — ivonescimab
8.4 months
PFS — durvalumab
5.8 months

This is an interim analysis; median follow-up 14.3 months. The upper limit of the confidence interval for overall survival in the ivonescimab arm could not be estimated (NE).

Endpoint details
Endpoint Ivonescimab + chemotherapy Durvalumab + chemotherapy Comparison
Median overall survival (primary) 14.9 months (12.9–NE) 12.1 months (11.0–13.4) HR 0.75 (0.61–0.92); one-sided p=0.0031
Overall survival at 12 months 59.7% 50.7% —
Overall survival at 18 months 44.0% 32.5% —
Median PFS 8.4 months (7.5–9.3) 5.8 months (5.6–7.2) HR 0.61 (0.51–0.72); one-sided p<0.0001
PFS rate at 6 months 68.7% 49.3% —
PFS rate at 9 months 49.3% 31.7% —
Objective response rate 53.8% (48.4–59.2) 32.5% (27.5–37.7) p<0.0001
Disease control rate 91.5% (88.0–94.2) 77.8% (73.0–82.1) —
Median duration of response Not reported Not reported —

Reading guide: in medians, the absolute difference is +2.8 months for overall survival and +2.6 months for PFS. In relative terms, the risk of loss of life is 25% lower for overall survival, and the risk of progression or loss of life is 39% lower for PFS. When explaining this to a patient, absolute months should come before relative percentages. The far ends of the curves are informative too: at 18 months the survival rates are 44.0% versus 32.5% (an 11.5-point difference). The announced p values are one-sided; the two-sided equivalent of 0.0031 for overall survival would be roughly double, around 0.006 (this calculation is ours), and still significant.

Subgroups: what was said and what was not?

Results by primary tumor location (ivonescimab / durvalumab)
Subgroup Overall survival HR (95% CI) PFS HR (95% CI) Response rate
Intrahepatic cholangiocarcinoma (198 vs 196 patients) 0.63 (0.48–0.83) 0.56 (confidence interval misprinted in the source) 54.0% vs 30.1%
Extrahepatic cholangiocarcinoma (65 vs 66 patients) 0.94 (0.57–1.55) 0.71 (0.47–1.08) 47.7% vs 36.4%
Gallbladder cancer (77 vs 80 patients) 0.95 (0.63–1.42) 0.66 (0.47–0.94) 58.4% vs 35.0%

These subgroup numbers must be read with caution. A clear difference in overall survival shows up only in the intrahepatic group (394 patients, more than half the trial). In the extrahepatic and gallbladder groups the overall survival HR is very close to 1 and the confidence intervals include 1; that is, no overall survival advantage was shown in these groups. These groups are small (65-80 patients), and the trial may not have been designed to answer the question separately in these subgroups. CancerNetwork writes that "results were consistent across subgroups"; that may be right for direction, but it does not reflect the overall survival confidence intervals. All the subgroup numbers come from the OncLive summary; they do not appear in other sources.

82.0% vs 72.3%Treatment-emergent adverse events (TEAEs), grade ≥3
43.4% vs 43.7%Serious TEAEs
3.5% vs 5.6%Treatment discontinuation due to adverse events
3.2% vs 3.8%TEAEs leading to loss of life
Selected adverse events (ivonescimab / durvalumab; safety set 339 / 339 patients)
Adverse event Ivonescimab + chemotherapy Durvalumab + chemotherapy
TEAE of any grade 100% 98.8%
Grade ≥3 TEAE 82.0% 72.3%
Serious TEAE 43.4% 43.7%
Treatment discontinuation due to adverse events 3.5% 5.6%
TEAE leading to loss of life 11 patients (3.2%) 13 patients (3.8%)
Neutrophil count decreased, grade 3/4 54.6% 41.3%
Immune-related adverse event, any grade 26.3% 22.1%
Immune-related adverse event, grade ≥3 4.1% 4.1%
Proteinuria 32.2% 11.8%
Hypertension 15.0% 2.4%
Hemorrhage 9.7% 6.5%
Median treatment exposure 7.8 months (0.4–19.9) 5.7 months (0.2–19.8)

The picture is mixed. The rate of serious events is the same in both arms (43.4% vs 43.7%), discontinuation is slightly less frequent in the ivonescimab arm (3.5% vs 5.6%), and events leading to loss of life are similar (11 and 13 patients); no immune-related loss of life was reported. On the other hand, grade ≥3 events are 9.7 points more frequent in the ivonescimab arm (82.0% vs 72.3%), and grade 3/4 neutrophil decrease is also higher (54.6% vs 41.3%). Events linked to VEGF inhibition, as expected, stand out in the ivonescimab arm: proteinuria 32.2% vs 11.8%, hypertension 15.0% vs 2.4%, hemorrhage 9.7% vs 6.5%. CancerNetwork writes that these events were mostly low grade and that no increase in grade ≥3 hemorrhage was seen; the presenters did not announce a new safety signal.

When reading the balance. Treatment duration is longer in the ivonescimab arm (median 7.8 months vs 5.7 months); in a group treated for longer, the chance of recording events naturally goes up. Exposure-adjusted rates are not available in the summaries we could see. Also, the adverse events published are "regardless of cause" (TEAE) events; treatment-related grade ≥3 rates and the causes of events leading to loss of life are not in the summaries. Because the trial is double-blind, less bias in adverse-event recording is expected than in open-label trials (this assessment is ours). Detailed toxicity analyses have not yet appeared.

How robust is this result?

Seven points to remember while reading:

  • Interim analysis. The overall survival advantage appeared at a preplanned interim analysis, at median follow-up of 14.3 months. The upper limit of the overall survival confidence interval in the ivonescimab arm could not be estimated; the number of events and the data cutoff date have not been published. The numbers may change as follow-up continues.
  • Single-region trial. The trial was run only at centers in China. Causes of biliary tract cancer, subtype distribution and treatment setting can differ between regions; these data say nothing about patient groups outside China. The US EA2251 trial will return to this question.
  • Sponsor analysis. According to Summit's statement, all relevant data were generated, managed and analyzed by Akeso; the overall survival interim analysis was assessed by an independent data monitoring committee (IDMC). There is no independent re-analysis, and the full paper has not yet been published.
  • Difference in subsequent therapy. More patients in the durvalumab arm received subsequent treatment (45.9% vs 31.8%). That may have narrowed the overall survival difference (this inference is ours); but which treatments were given, and when, has not been published.
  • Uneven picture across subgroups. The overall survival advantage is clear in the intrahepatic group; it was not shown in the extrahepatic and gallbladder groups. See the warning above.
  • Safety balance. Grade ≥3 events and VEGF-related toxicity are more frequent. Whether the gain in survival and progression-free time is worth this price is a question to be weighed patient by patient.
  • Secondary sources. We could not access the full text in NEJM or another journal, nor the ESMO presentation; the numbers were collected from the OncLive, CancerNetwork and OncoDaily summaries. The main numbers agree across the sources; small differences (for example, the wording "new standard" versus "potential new standard", and the "TEAE-related" label on discontinuation) are noted below.

What happens next?

2022-2023

With TOPAZ-1 (durvalumab) and KEYNOTE-966 (pembrolizumab), adding immunotherapy to gemcitabine–cisplatin became the first-line standard.

February 2026

China's NMPA granted ivonescimab + chemotherapy "breakthrough therapy" status in biliary tract cancer.

25 August 2026

Akeso announced, without numbers, that HARMONi-GI1 had met its overall survival, PFS and response rate goals at the interim analysis.

21 October 2026

ECOG-ACRIN announced in the US the phase 2/3 EA2251 trial, which will compare ivonescimab + gemcitabine–cisplatin with pembrolizumab or durvalumab + gemcitabine–cisplatin (the primary endpoint is overall survival; sites are expected to activate in the fourth quarter of 2026).

25 October 2026

The results were presented at ESMO 2026 (LBA8).

Next

Akeso said that detailed results will be published in a peer-reviewed journal; the date is unknown. No regulatory filing for biliary tract cancer outside China has been published; we could not verify the filing status in China.

The situation in Türkiye. Ivonescimab is not approved for any indication in the US or Europe; we could not find any information on its licensing or reimbursement in Türkiye. The trial was run in China; there is no information on a center in Türkiye. The licensing and reimbursement status of the durvalumab and pembrolizumab combinations in biliary tract cancer in Türkiye could not be verified (we could not access the TİTCK and SGK databases); we have drawn no assumptions. FDA approval, a TİTCK license and SGK reimbursement are three separate processes; we explained them in FDA-approved new cancer drugs and the access map in Türkiye and unlicensed cancer drugs (both in Turkish). Taking part in clinical trials (in Turkish) can be one way to reach new drugs.

DROZDOGAN Academy Commentary

This result is a strong signal that adding a second target (VEGF) to immunotherapy may work in first-line biliary tract cancer. But it is a single-region interim analysis; it is too early to speak of a "new standard".

⚡ Why it matters

First-line options in biliary tract cancer are limited, and median overall survival is still about one year. In a double-blind phase 3 whose control arm already contains immunotherapy, HARMONi-GI1 announced an advantage in overall survival, PFS and response rate — although "new standard" is the researcher's own interpretation, and the "first phase 3" description has not been independently verified.

✅ What is strong

A randomized, double-blind, 682-patient phase 3; the control arm is the current standard, the durvalumab combination. Overall survival (HR 0.75), PFS (HR 0.61) and response rate (53.8% vs 32.5%) all point the same way; the overall survival rates at 12 and 18 months also favor the combination. The rate of serious events and events leading to loss of life are similar in the two arms.

⚠️ What is weak

An interim analysis with short follow-up; one region (China); the sponsor's own analysis and no full paper. The overall survival advantage is clear only in the intrahepatic group; it was not shown in the extrahepatic and gallbladder groups. Grade ≥3 adverse events (82.0% vs 72.3%) and VEGF-related events (proteinuria, hypertension, hemorrhage) are more frequent in the ivonescimab arm; there are no exposure-adjusted rates.

🩺 What it means in practice for patients and physicians

As of today there is no practical change: ivonescimab is not approved for biliary tract cancer in any country, and no treatment decision can be made on these data. Still, talking with the oncologist about first-line options in advanced biliary tract cancer, about whether the tumor's molecular features have been studied, and about open clinical trials is the concrete expression of this data. Western data will come from the US EA2251 trial.

❓ Open questions

Will the overall survival difference hold as follow-up continues? Will the difference appear in patients outside China? Does the combination give a benefit in extrahepatic and gallbladder cancer? What will the exposure-adjusted adverse-event picture look like? And the most practical question: when will the full paper be published, and where and when will regulatory filings be made?

Bottom line: In a double-blind phase 3 run in China, at an interim analysis, ivonescimab + gemcitabine–cisplatin did better than the durvalumab combination in overall survival, PFS and response rate; the price is more frequent grade ≥3 adverse events and VEGF-related toxicity. It is a strong signal, but because of the single region, the interim analysis, and the absence of full publication and approval, it is not yet finished evidence. "New standard" is currently the interpretation of the researcher and the company, not a regulatory decision.

Frequently asked questions

What did the HARMONi-GI1 trial show?
In first-line advanced biliary tract cancer, ivonescimab + gemcitabine–cisplatin gave a median overall survival of 14.9 months versus 12.1 months and a median progression-free survival of 8.4 months versus 5.8 months, compared with durvalumab + gemcitabine–cisplatin. The response rate was 53.8% versus 32.5%. The results come from a preplanned interim analysis.
What is ivonescimab?
An intravenous bispecific antibody that targets PD-1 and VEGF at the same time. It is approved in China only for lung cancer; it is not approved for any indication in the US or Europe. No approval for biliary tract cancer has been announced.
Why is this result not considered "final"?
Because it is an interim analysis, follow-up is short, the trial was run only in China, the data were analyzed by the sponsor, and the full paper does not yet exist. In addition, the overall survival advantage is clear only in the intrahepatic group.
Can this treatment be used in Türkiye?
We could not find information that ivonescimab is licensed or reimbursed in Türkiye; it is not approved in the US or Europe either. Only the treating oncologist can assess clinical-trial or special-access options.
What adverse events does the combination have?
The most frequent were events affecting blood cells (hematologic); grade 3/4 neutrophil decrease was 54.6% vs 41.3%. Among VEGF-related events, proteinuria was 32.2% vs 11.8%, hypertension 15.0% vs 2.4% and hemorrhage 9.7% vs 6.5%. Grade ≥3 adverse events were more frequent (82.0% vs 72.3%); serious events were at the same level in the two arms.
Was the benefit seen in all subtypes of biliary tract cancer?
A clear overall survival benefit was seen in intrahepatic cholangiocarcinoma (HR 0.63). In extrahepatic cholangiocarcinoma (HR 0.94) and gallbladder cancer (HR 0.95), no overall survival advantage was shown; these groups are small and their confidence intervals include 1.
Is ivonescimab already a standard treatment?
No. "New standard" is the interpretation of the presenting researcher; ivonescimab is not approved for biliary tract cancer in any country, and in the US a separate trial (EA2251) to test the same question is only now starting.

Glossary

Biliary tract cancer
The collective name for cancers arising from the bile ducts inside or outside the liver (cholangiocarcinoma) or from the gallbladder.
Bispecific antibody
A single antibody molecule that can bind two different targets at the same time. Ivonescimab binds PD-1 and VEGF.
PD-1 / PD-L1
A pair of "checkpoints" on immune cells and tumors that can brake the immune response. Durvalumab binds PD-L1; ivonescimab binds PD-1.
VEGF
A growth factor that helps a tumor form new blood vessels; inhibiting it can cause adverse events such as proteinuria and hypertension.
Overall survival (OS)
The time until loss of life from any cause; the gold-standard endpoint in oncology.
PFS (progression-free survival)
The time from the start of treatment until the disease progresses or loss of life occurs.
HR (hazard ratio)
The ratio of the rate at which an event occurs in two groups. Below 1 favors the experimental arm; if the confidence interval includes 1, the difference is not statistically certain.
Objective response rate / disease control rate
The share of patients whose tumor shrank to some degree / the share of patients whose tumor shrank or stayed stable.
Interim analysis and IDMC
An analysis done at a prespecified point before the trial ends; an independent data monitoring committee (IDMC) reviews this analysis and safety. A difference found at an interim analysis can change as follow-up continues.
TEAE
Treatment-emergent adverse event; any adverse event during the treatment period, whether or not the drug is the cause.

Transparency note. Verified: the trial's NCT number, design, arms, doses, patient numbers, numbers for primary and secondary endpoints, and subgroup and safety numbers (from the OncLive summary; the main numbers are consistent in CancerNetwork and OncoDaily too); presentation information (Summit's statement); the announcement of the EA2251 trial; the NMPA breakthrough therapy decision of February 2026; the TOPAZ-1 and KEYNOTE-966 numbers (from secondary summaries). Not verified, and therefore not written in: the full text in a journal and the ESMO presentation (we could not access them; the numbers are from secondary sources); the data cutoff date; the number of overall survival events; baseline patient characteristics; duration of response; the confidence interval for PFS in the intrahepatic group (misprinted in the source); details of subsequent therapy (not fully consistent across sources); exposure-adjusted adverse-event rates; causes of events leading to loss of life; the number of centers; CancerNetwork's "priority review in China" information and the filing status in China; the licensing and reimbursement status in Türkiye of ivonescimab and of durvalumab/pembrolizumab in biliary tract cancer; the current content of the ClinicalTrials.gov record. Small inconsistencies: Zhou's result is relayed as a "new standard" in OncLive and as a "potential new standard" in OncoDaily; the discontinuation rate (3.5% vs 5.6%) is labeled "TEAE-related" in OncLive but "treatment-related" in our original infographic; the 9-month PFS rate (49.3% vs 31.7%) appears only in the OncLive summary, and the combination-arm value matches the control arm's 6-month value (it may be a coincidence; we could not verify it). Source note: "new standard" and "major breakthrough" belong to the researcher and the company, and the "first phase 3" description to Zhou and Akeso; the text says so. Assessments and commentary belong to this article. This article is not medical advice; no treatment decision should be made on the basis of this text.

References

  1. Zhou J, et al. Ivonescimab plus chemotherapy versus durvalumab plus chemotherapy as first-line treatment for advanced biliary tract cancer: a randomized, controlled, double-blinded, phase 3 trial (HARMONi-GI1). ESMO 2026, LBA8, Presidential Symposium II. 25 October 2026. (Publication of the full text could not be verified.)
  2. OncLive. Ivonescimab Plus Chemotherapy Represents a New SOC in First-Line Biliary Tract Cancer. 25 October 2026. onclive.com
  3. CancerNetwork. Ivonescimab Combo Improves Survival in Advanced Biliary Tract Cancer. 25 October 2026. cancernetwork.com
  4. OncoDaily. HARMONi-GI1 at ESMO 2026: Ivonescimab Plus Chemotherapy in Advanced Biliary Tract Cancer. 25 October 2026. oncodaily.com
  5. OncLive. First-Line Ivonescimab Plus Chemotherapy Meets OS End Point in Advanced Biliary Tract Cancer. 26 August 2026. onclive.com
  6. Clinical Trials Arena. Summit and Akeso's ivonescimab biliary tract cancer Phase III. 26 August 2026. clinicaltrialsarena.com
  7. Summit Therapeutics. HARMONi-GI1 to be showcased in Presidential Symposium at ESMO 2026 (summary by BioPharmaWatch). biopharmawatch.com
  8. News-Medical. ECOG-ACRIN opens trial testing ivonescimab for aggressive bile duct cancer. 21 October 2026. news-medical.net
  9. PharmaShots. Akeso's Ivonescimab + CT Receives the NMPA Breakthrough Therapy Designation for Biliary Tract Cancer. 6 February 2026. pharmashots.com
  10. TOPAZ-1: Updated Results from the TOPAZ-1 Study of Durvalumab plus GemCis in Patients with Advanced BTC. jhoponline.com; KEYNOTE-966: Healio. Pembrolizumab plus chemotherapy prolongs survival in advanced biliary tract cancer. healio.com
  11. ClinicalTrials.gov. NCT06591520 (HARMONi-GI1); NCT07765433 (EA2251).
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