Practice-changing data in lung cancer, prostate cancer and more were on display over the weekend at the American Society of Clinical Oncology annual meeting in Chicago. Plus, early readouts on assets that could reshape the cancer landscape.
The American Society of Clinical Oncology (ASCO) conference was in full swing in Chicago this weekend, with researchers from around the world showcasing paradigm-shifting results and the next generation of cancer therapeutics.
Revolution Medicines’ groundbreaking pancreatic cancer candidate daraxonrasib and Chinese biopharma Akeso and partner Summit Therapeutics’ PD-1/VEGF inhibitor ivonescimab grabbed the most attention. But others, including Bristol Myers Squibb and BioNTech, Johnson & Johnson and Gilead Sciences posted compelling and potentially practice-changing data in lung, prostate and ovarian cancer.
Here are some readouts that caught our attention.
BioNTech and BMS score in the bispecific battle
In the race of the PD-1/VEGF bispecific antibodies, BioNTech and BMS revealed Phase 2 data for their inhibitor pumitamig from the ROSETTA Lung-02 trial. The results included data from 40 patients with previously untreated advanced non-small cell lung cancer (NSCLC) treated with pumitamig plus chemotherapy in a global population.
At nine months, the combination showed a confirmed objective response rate of 57.1% in patients with non-squamous NSCLC and 68.4% in patients with squamous NSCLC, and a disease control rate of 100%. Grade 3 treatment-related adverse events (TRAEs) thought to be related to pumitamig occurred in 23.3% of patients, with treatment discontinuation at 9.3%.
“We see this as comparable to ivonescimab,” Truist Securities wrote in a note on Sunday.
The pivotal Phase 3 ROSETTA Lung-02 trial is actively enrolling, BioNTech and BMS said in their press releases, along with two other Phase 3 trials in NSCLC. Pumitamig is also advancing in small-cell lung, triple-negative breast, colorectal and gastric cancers.
J&J’s practice-changing shift in prostate cancer
Johnson & Johnson’s Erleada before and after surgery significantly improved outcomes for patients with high-risk localized prostate cancer, according to the Phase 3 PROTEUS readout. The results could set a new standard of care in a setting where nearly half of patients who undergo curative surgery experience relapse.
The trial enrolled some 2,100 patients to test frontline Erleada plus androgen-deprivation therapy (ADT) versus ADT plus placebo, with patients getting the treatment six months before and after radical prostatectomy. At about five years, the combination reduced the risk of developing metastasis or death by 20%, and five-year metastasis-free survival increased from 73.5% in the placebo group to 78.2% for patients who took Erleada. Nearly 9% of patients had a pathological complete response, compared to 1% of patients in the control arm.
But while Erleada clearly improves outcomes, the drug has not yet been directly compared to other treatment options including upfront surgery, William K. Oh, director of precision medicine for Yale Cancer Center and an ASCO expert in genitourinary medicine, said in a press release.
Incyte’s Monjuvi in first-line diffuse large B cell lymphoma
Incyte could shift the standard of first-line (1L) care in diffuse large B cell lymphoma (DLBCL), where a chemotherapy regimen called R-CHOP reigned for decades. The Phase 3 frontMind trial put Incyte’s anti-CD19 monoclonal antibody Monjuvi/Minjuvi plus lenalidomide plus R-CHOP up against R-CHOP alone. The combo reduced the risk of disease or death by 25% in previously untreated high-intermediate or high-risk DLBCL patients, and 67.3% patients on the combo were alive and progression-free at three years, compared to 60.7% in the control arm.
“We anticipate likely approval in 1L DLBCL early 2027 at the latest and note a nearly doubled market opportunity from [relapsed or refractory] DLBCL alone,” Trust Securities wrote in its Sunday note.
Such an approval would set up competition with Roche’s antibody-drug conjugate Polivy, which the FDA approved in the same setting in 2023. Trust Securities noted that the pair appear to have comparable efficacy.
A solid bet by Gilead
Meanwhile, a readout of Phase 1 data for the antibody-drug conjugate (ADC) TUB-040 came with good news for Gilead.
The dose-escalation trial, called NAPISTAR 1-01, evaluated dose levels of 1.67 mg/kg and 3.3 mg/kg for patients with platinum-resistant ovarian cancer. Among 46 patients, some 60.9% of them saw their tumors shrink, including 57% with a partial response and 4% with a complete response. The ADC targets NaPi2b, a cell-surface protein overexpressed in serious ovarian cancers (PROC) and NSCLC. It appeared to be well tolerated.
“NAPISTAR 1-01 data of TUB-040 (NaPi2b ADC) in PROC appear consistent with the abstract, with promising efficacy and a manageable safety profile,” Leerink Partners wrote in a Monday morning note.
TUB-040 is the lead asset from German biotech Tubulis, which Gilead snatched up earlier this year for $3.15 billion in cash and up to $1.85 billion in potential milestone payments. The acquisition closed a little over a week ago.
Eli Lilly present ‘extraordinary’ data in RET fusion-positive lung cancer
Along with J&J’s PROTEUS readout, Eli Lilly scored a spot in the plenary on Sunday—with good reason. Its RET inhibitor Retevmo led to a significant 83% reduction in the risk of disease or death in the adjuvant setting for people with early-stage, RET fusion–positive NSCLC.
The Phase 3 LIBRETTO-432 trial consisted of 151 previously treated patients with early-stage, RET-positive NSCLC, who were given either Retevmo or placebo for up to three years after their main treatment. At two years, the event-free survival (EFS) rate was 91.5% for patients taking Retevmo, versus 61.1% for placebo.
The trial was the first to evaluate a RET kinase inhibitor as adjuvant therapy in early-stage, RET-altered NSCLC. “Already the RET standard of care, Retevmo’s adjuvant study showed striking curves; the Retevmo arm only had two events,” Leerink Partners wrote to investors Monday morning.
Jake Van Naarden, Lilly’s president of Oncology and head of Corporate Business Development, “sees the results as helping to drive broader testing paradigms in early-stage lung, where EGFR and ALK are more commonly tested today,” the analysts added.
