#ASCO25 Tracker: BioNTech, OSE Tout Positive Data in Difficult Cancers

Roche and Jazz Pharmaceuticals presented Phase III data Monday at ASCO25, hoping to bolster their case for approval of a Tecentriq/Zepzelca combo in first-line small cell lung cancer (SCLC).

Results from the trial, which consisted of 660 people with extensive-stage SCLC, showed median progression-free survival of 5.4 months in the combination arm, compared to 2.1 months in people treated with Tecentriq alone, and median overall survival of 13.2 months with the combo compared to 10.6 months with Tecentriq monotherapy. These differences were statistically significant, according to Jazz’s press release.

Jazz has filed for FDA approval of the combination and CMO Rob Iannone told BioSpace in an interview that he expects “to get priority review, which would allow us to get an approval this year.”

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A day after committing $3.5 billion plus potential milestones to BioNTech to co-develop a solid tumor bispecific, Bristol Myers Squibb got a peak at some new data for the drug.

At ASCO on Monday, BioNTech reported Phase II data from a trial of the experimental PD-L1xVEGF, combined with chemotherapy, in 31 patients with mesothelioma. More than half of the enrolled patients (16), saw their tumors shrink by at least 30%, according to Endpoints News, and six of eight patients with a particularly difficult form of the disease responded to treatment.

An often less discussed form of immunotherapy, cancer vaccines are waiting in the wings—and making progress in the clinic. OSE Immunotherapeutics reported in March that its “off-the-shelf” neo-epitope-based therapeutic cancer vaccine Tedopi hit the primary endpoint in a Phase II trial in advanced pancreatic cancer, showing “positive outcomes” in terms of overall survival (OS).

Monday, OSE expanded on these survival data at ASCO25. When treated with Tedopi, in combination with chemotherapy, 54 patients experienced an OS rate of 65% at 12 months compared to those taking chemo alone. Pancreatic cancer is very difficult to treat, as it is often caught late, after it has metastasized. Notably, OSE said in its press release that patients in the control group survived an “unexpectedly long” 17 months, as opposed to the usual 10-12 months.

Two patients achieved a complete response with Tedopi and chemo compared to zero in the chemo only group.

AstraZeneca and Daiichi Sankyo’s Enhertu plus Roche’s Perjeta could be a powerful combination for patients with HER2-positive advanced or metastatic breast cancer—that’s according to data from the Phase III Destiny-Breast09 trial presented at ASCO25 on Monday.

The combination showed a median progression-free survival of greater than three years, according to the companies, representing the first trial in more than a decade to demonstrate an improvement in outcomes in the first-line setting for a broad population of patients with this type of breast cancer.

Overall, 15% of patients given the combo enjoyed a complete response following treatment vs. 8.5% of those on standard of care taxane, trastuzumab and Perjeta.

Vishwanath Sathyanarayanan, a medical oncologist and an academic advisor at Apollo Hospitals in Bangalore, India, called the results “definitely practice-changing,” according to Biopharma Dive.

“With a median progression-free survival of more than three years, the DESTINY-Breast09 results show [Enhertu] combined with [Perjeta] has the potential to become a new first-line standard of care for these patients,” Sara Tolaney, chief of the division of Breast Oncology at the Dana-Farber Cancer Institute and principal investigator of the Destiny-Breast09 trial, said in a statement.

Arcus Biosciences on Sunday presented updated data from a Phase I/Ib trial of its kidney cancer candidate casdatifan, an asset it hopes will provide a formidable challenge to Merck’s Welireg. At the cut-off for this weekend’s oral ASCO25 presentation, patients treated with casdatifan in combination with Exelixis’ Cabometyx had seen an average 46% response rate. Of 24 patients with metastatic kidney cancer, one participant saw a complete response, while 10 others experienced partial responses.

With these data in hand, Arcus will launch a Phase III trial of the combo in kidney cancer patients who have previously received an anti-PD-1/L1 immunotherapy. Casdatifan will have an uphill battle to compete with Welireg, which secured FDA approval in advanced renal cell carcinoma in 2023.

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Back in April, Amgen teased initial survival details from the Phase III DeLLphi-304 trial for its bispecific T-cell engager Imdelltra, saying the trial met its primary endpoint without offering further details. At ASCO25, the company is back with more data, showing a 40% improvement in survival and a better safety profile compared to chemotherapy in patients with small-cell lung cancer (SCLC) who had previously tried platinum-based chemotherapy. Patients treated with Imdelltra lived for 13.6 months, versus 8.3 months on chemotherapy.

The drug won FDA accelerated approval in May 2024, and data from this trial is intended to extend that approval and potentially convert it into a full approval down the line.

Boston-based Bicara Therapeutics released solid data Sunday from its head and neck cancer drug ficerafusp alfa in combination with Merck’s Keytruda, showing a two-year overall survival rate of 46% and confirmed objective response rate of 54%. These results were not enough to impress investors, however, in the context of rival Merus, which just over a week ago knocked investors’ socks off, reporting a nearly 80% overall survival rate in certain patients with HNSCC.

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In January, AstraZeneca and Daiichi Sankyo won their first FDA approval for datopotamab deruxtecan (Dato-DXd)—Datroway—for breast cancer. The partners haven’t been so successful in lung cancer.

In May 2024, Datroway failed to significantly improve overall survival in patients with non-small cell lung cancer (NSCLC). A year later, the oncology partners continue to try to make the case for the ADC in NSCLC.

On Sunday at ASCO25, Astra and Daiichi presented data from three early-stage trials, the cumulative of which they say “continue to demonstrate the potential of Datroway in combination with various immunotherapies to improve outcomes in patients with non-small cell lung cancer (NSCLC) across multiple stages of the disease.”

Astra and Daiichi presented final data from the TROPION-Lung02 trial testing Datroway in combination with Merck’s Keytruda. In 42 patients receiving the combo, an objective response rate (ORR) of 54.8% was observed; 54 patients who were given firstline triplet Datroway plus Keytruda and platinum chemotherapy saw an ORR of 55.6%.

“A strong trend towards higher efficacy in TROP2-NMR-positive (T2NMR+) patients was observed, boosting our confidence that a similar analysis of the AVANZAR study will also succeed,” Jefferies analysts wrote in a note to investors on Sunday. “The lack of stat sig reflects a small sample size, and doublet therapy beating triplet may reflect sicker patients and lower doses in the triplet arm.”

Final results from cohort 5 of the TROPION-Lung04 phase Ib trial, which paired Datroway with AstraZeneca’s PD-1/TIGIT bispecific antibody rilvegostomig in the firstline setting, also spoke to the ADC’s potential as a combination treatment. Forty patients with advanced or metastatic NSCLC treated with the combo saw an ORR of 57.5%, with one complete response and 22 partial responses observed.

“TROPION-Lung02 and TROPION-Lung04 phase 1b results support combination of Daiichi Sankyo and AstraZeneca’s DATROWAY with immunotherapy as first-line treatment for advanced or metastatic NSCLC,” the companies said in a press release announcing the results.

Texas-based Actuate Therapeutics presented what it called “breakthrough results” at ASCO25 this weekend from a Phase II trial of elraglusib, in combination with treatment staples gemcitabine and nab-paclitaxel (GnP), in previously untreated metastatic pancreatic cancer.

The trial met its primary endpoint, with the elraglusib-based regimen extending median overall survival to 10.1 months compared to 7.2 months for GnP alone. This equates to a 37% reduction in risk of death, according to Actuate’s Saturday press release.

Additionally, the 12-month survival rate doubled with elraglusib compared to GnP alone, from 22.3% to 44.1%, “marking a clinically meaningful advance for a cancer with few recent treatment breakthroughs,” Actuate stated. According to Johns Hopkins, the five-year survival rate for stage 4 pancreatic cancer—when the disease has metastasized—is just 1%. The safety profile for elraglusib, a GSK-3β inhibitor therapy, was “favorable,” with most side effects being mild and manageable, according to the biotech.

Actuate plans to engage with the FDA later this year to discuss a path to registration.

In March, Takeda and Protagonist Therapeutics reported that their injectable drug rusfertide met the primary endpoint in the Phase III VERIFY study in patients with polycythemia vera (PV)—a rare blood disorder that leads to overproduction of red blood cells, putting sufferers at higher risk for heart-related events. Sunday, the partners were back at ASCO25 with further data.

Treatment with rusfertide plus current standard of care (SOC) more than doubled clinical response rates across high- and low-risk PV groups, reducing the need for phlebotomy, compared to placebo, plus SOC, meeting the primary endpoint. Rusfertide also hit all secondry endpoints, including reducing the proportion of patients requiring phlebotomy nearly threefold and eliciting a nearly fourfold improvement in hematocrit control compared to placebo.

The positive results are a comeback story for rusfertide, which in 2021 was placed on clinical hold by the FDA after mice receiving the drug developed skin tumors. In 2022, the agency threatened to rescind the drug’s breakthrough designation. Rusfertide has also received both Orphan Drug and Fast Track designation from the FDA, according to a press release issued Sunday by Takeda and Protagonist.

In one of ASCO25’s most highly anticipated presentations, AstraZeneca will present data Sunday showing that when breast cancer patients with ESR1 mutations were switched to its investigational oral SERD camizestrant, in addition to a CDK4/6 inhibitor, they saw a 56% reduction in the risk of disease progression or death compared to those who remained on their original treatment.

Camizestrant is the first next-generation oral SERD to generate consistent progression-free survival in combination with widely approved CDK4/6 inhibitors in first-line advanced breast cancer, according to an AstraZeneca press release.

The Phase III SERENA-6 study is also “the first pivotal trial to demonstrate clinical value of monitoring circulating tumor DNA to detect and treat emerging resistance in 1st-line therapy ahead of disease progression in breast cancer,” AstraZeneca said.

In an interview with Endpoints News, however, one expert questioned the study design of switching patients to camizestrant before their tumors progressed. “How many patients do you have to screen to find one who’s a candidate for the study?” asked Harold Burstein, an oncologist at Dana-Farber Cancer Institute who was not involved in the study. “If you have to screen two or three patients, well, that’s probably bearable in some way. If you have to screen eight to ten patients to find one who might be a candidate, that’s a lot of work.”

AstraZeneca first announced the positive trial result in February but did not elaborate on the details at the time.

First approved in 2015 for treating patients with metastatic pancreatic adenocarcinoma (mPDAC) who have received gemcitabine-based treatment, Ipsen’s Onivyde moved into frontline treatment in February 2024, when the FDA approved the topoisomerase inhibitor plus the chemo regimen for initial treatment. It was the first new frontline treatment for the indication in a decade. On Day 2 of ASCO 2025, the company presented data that showed the use of the drug in that setting pushed median overall survival to 19.5 months in some patients.

That data come from the company’s Phase III NAPOLI 3 study. That trial studied 120 patients who were treated with Onivyde plus a chemotherapeutic regimen. The analysis Ipsen presented focused on 15 patients who survived to 18 months. According to Ipsen’s announcement, patients with PDAC are often not diagnosed until the disease has metastasized, after which survival to more than one year is less than 20%.

The new data continue progress for Ipsen in the oncology space. In July 2024 the company got ex-U.S. licensing rights to Day One’s Ojemda, which is already FDA approved for pediatric gliomas. According to an investor note from Leerink Partners on May 15, Ipsen has already submitted the product for EMA approval with an eye towards a decision at the end of the year.

In 2021, Pfizer and Arvinas struck a $1 billion-plus protein degrader collaboration. Since then, the partnership has yielded mixed results at best. In March, the companies announced data from a Phase III trial showing that PROTAC degrader vepdegestrant could improve progression-free survival in breast cancer patients—but only in those carrying a mutation in the estrogen receptor 1 (ESR1) gene.

At the time, BMO Capital Markets said that establishing efficacy in the wild-type population could have opened up approximately “$4 billion in additional revenue upside for vepdegestrant across treatment lines.”

At ASCO 2025 on Saturday, Pfizer released further details from the same Phase III VERITAC-2 trial, showing that vepdegestrant cut the risk of disease progression or death by 43% over hormone therapy in this subpopulation. According to Endpoints News, however, these data put vepdegestrant roughly on the same level as Menarini’s Orserdu, which has been on the market since 2023.

Vepdegestrant is “the first and only [PROTAC] evaluated in a Phase 3 clinical trial and the first to show benefit in patients with breast cancer,” according to a statement put out Saturday by the partners.

Despite the mixed data, Pfizer and Arvinas plan to submit a new drug application to the FDA in the second half of this year.

Xofigo—a bone-targeting drug that delivers a radioactive dose of Radium-223—got its first FDA approval back in 2013 for castration-resistant prostate cancer with bone metastases. Now, Bayer is back with fresh data aiming to show its continued value, with new figures from the company’s Phase III PEACE III trial.

Xofigo in combination with enzalutamide, a hormone-targeting chemotherapy used for prostate cancer, beat out enzalutamide alone in metastatic castration-resistant prostate cancer (mCRPC) with bone metastases. Adding Xofigo to enzalutamide reduced risk of progression or death by 31% compared to enzalutamide alone.

Bayer is showing off Xofigo at ASCO, with two more presentations of new data for the drug – even more PEACE III data on Xofigo’s effects on biomarker improvement, as well as data from the Phase II COMRADE trial, also in mCRPC, showing improvements in radiographic progression-free survival when used in combination with AstraZeneca’s and Merck’s chemotherapy olaparib.

Biotech giant Gilead Sciences and its cancer-focused subsidiary Kite Biopharma have a spate of abstracts across ASCO25. Gilead made a big splash Saturday morning, announcing that its blockbuster ADC Trodelvy, in combination with Merck’s Keytruda, reduced the risk of death by 35% in patients with PD-L1+ metastatic triple-negative breast cancer, compared to Keytruda and chemotherapy alone. These data will be presented in a late-breaking oral presentation Saturday afternoon.

The results come from the companies’ Phase III ASCENT-04/KEYNOTE-D19, which met its primary endpoint, with the power combo extending progression-free survival to 11.2 months, versus 7.8 months for Keytruda and chemotherapy alone.

That trial is the result of a collaboration between Gilead and Merck, announced in 2021, to investigate the combination in triple-negative breast cancer. Gilead announced initial topline data in late April, stating that the drug regimen “significantly improved” progression-free survival, without putting data forward at that time.

In November 2024, BeiGene announced that it was changing its name to BeOne Medicines, with a new logo included. The rebranding was an effort to “reaffirm its commitment to creating cancer therapies,” as well as a promise to bring “10 new potential medicines into the clinic” in 2025. On Saturday at ASCO, the company presented a full slate of new data, mostly on already approved assets.

Leading BeOne’s 23 different abstracts at the conference were two new data readouts from long-term follow-ups in the Phase III SEQUOIA trial in chronic lymphocytic leukemia of Brukinsa, the company’s BTK inhibitor, which carries a host of approvals across a number of different cancers. Of 114 patients, 92%, achieved 24-month progression-free survival and an overall response rate of 97%. In patients with high-risk disease, 11 patients were able to stop treatment early, and nine remained in clinical remission.

BeOne’s Head of R&D Lai Wang added in a statement that nearly 88% of patients with del(17p) and /or TP53 mutations treated with Brukinsa plus venetoclax remain progression-free at 36 months.

The company also showed new results from PD-1 blocker Tevimbra, touting a “tolerable safety profile” in the neoadjuvant setting for resectable esophageal squamous cell carcinoma.

When asked about the company’s new name and strategy, Mark Lanasa, chief medical officer for solid tumors, told BioSpace, “Our strategy has not changed. The name change is an affirmation of who we are, one team meeting patients wherever they are.”

BeOne’s new data comes on the heels of the company’s decision to drop its anti-TIGIT molecule ociperlimab for non-small cell lung cancer, after an independent monitoring board found it unlikely to be effective. That decision left the company with no TIGIT-related molecules in its pipeline.

Almost exactly a year ago, at ASCO2024, Merck KGaA showed initial Phase I data for precemtabart tocentecan, its anti-CEACAM5 antibody drug conjugate, in metastatic colorectal cancer. At ASCO2025, the company is back with new dose optimization data from the same trial, showing “encouraging efficacy and safety data,” with no new safety findings.

This new spate of data dialed in on a dose to continue with Phase II development. The company selected 2.8 kg/mg, the higher of two tested doses, which showed an overall response rate of 24.1%, a number the company said compares favorably with standard-of-care monotherapy (which has an ORR of 1-2%). The most common safety signals were anemia and neutropenia, and while there were no reported treatment-related deaths, there was a 43% discontinuation rate, with nine patient dropouts and one death while in the trial.

Precemtabart tocentecan is an ADC that targets the protein CEACAM5 and delivers exatecan, a classical topoisomerase inhibitor chemotherapeutic.

Astellas joined a rapidly growing trend Thursday when it plunked down $130 million upfront for exclusive worldwide rights to Evopoint Biosciences’ XNW27011, an early-stage ADC designed to target the protein Claudin18.2.

During a press conference at ASCO Friday morning, Astellas Chief Strategy Officer Adam Pearson addressed the deal. “I think we’re always on the lookout for great innovation,” he said.

With the alliance, which could see Evopoint take home as much as $1.5 billion in total, plus royalties on net sales of the ADC, if approved, Astellas joins a growing list of companies looking East for effective cancer therapeutics that also includes Pfizer, Bayer and others. In fact, in a May 21 note to investors, Truist Securities said that nearly a third of presentations at ASCO this year involve assets that came from Chinese companies.

However, Pearson said Astellas was not specifically looking to China or for an ADC. “We were scanning the space, not specifically China or ADCs, but we were looking for assets that could play a role in treating patients with gastric or pancreatic cancer,” he told attendees.

“Because it’s targeted at CLDN18.2 and we have experience there too, we thought we could add value and it could make a difference for patients in that space.” Astellas also felt that XNW27011 complimented its own Vyloy, a claudin 18.2–targeted therapy approved by the FDA for certain gastric cancers, Pearson added.

Pfizer is on the hunt for a full approval of its anti-cancer small molecule kinase inhibitor Braftovi in colorectal cancer. The company won the FDA’s accelerated approval in December 2024, and is pushing for a full nod this year. Top of mind: a 51% risk reduction in death compared to standard-of-care.

In February, Pfizer reported topline data from the Phase III BREAKWATER study, showing that a combination regimen featuring the asset significantly improves survival in certain patients. The company elaborated on the results Friday. The trial, which will be featured in a full presentation at ASCO, met its dual primary endpoint of progression-free survival, showing a 47% risk reduction in disease progression or death compared to standard-of-care. Patients who received Braftovi plus a suite of chemotherapies survived for 30 months compared to 15 months for patients on standard-of-care.

“The risk of death for patients with BRAF V600E-mutant metastatic colorectal cancer is more than double compared to those with no known mutation,” said Michael Sapienza, CEO of the Colorectal Cancer Alliance, in a statement.

“The BREAKWATER survival data are being discussed with the U.S. FDA to support potential conversion to full approval in 2025,” according to Pfizer’s announcement.

As ASCO conference goers arrived at Chicago’s McCormick Place conference center Friday, they learned that Merck would present new data from a Phase II trial of its antibody-drug conjugate (ADC) zilovertamab vedotin in patients with relapsed or refractory diffuse large B cell lymphoma, in combination with standard of care treatments.

The waveLINE-003 trial tested the drug at three different dose levels, 1.5, 1.75 and 2.0 mg/kg. Merck touted the results from 1.75 mg/kg arm, where 16 patients saw a 56.3% objective response rate. Across all 41 patients in the trial, 98% saw adverse effects. Based on the analysis of all three doses after a 9.8-month median follow-up period, Merck selected the 1.75 mg/kg dose for its upcoming Phase III trial for the same drug, which was announced in February and is already enrolling.

Zilovertamab vedotin has also shown high potential in diffuse large B cell lymphoma. In December 2024, Merck reported that the ADC delivered a 100% complete response rate when used as part of a treatment regimen in these patients. Analysts at the time called the data “very competitive” but raised questions about safety as grade 3 to 4 treatment-related adverse events in 58% of the trial’s participants.