2025 Data Across Gynecologic, Lung, and Hematologic Cancers Reshape Treatment Landscapes

Over the course of 2025, clinical trial data presented during major medical meetings across lung and gynecologic cancers, as well as hematologic malignancies, made major waves. Notable advances included the emergence of relacorilant (CORT125134) in platinum-resistant ovarian cancer (PROC), the confirmation of the role of tarlatamab-dlle (Imdelltra) in extensive-stage small cell lung cancer (ES-SCLC), and event-free survival (EFS) improvement with venetoclax (Venclexta) plus a hypomethylating agent (HMA) in induction-eligible acute myeloid leukemia (AML).

To give perspective on how the latest data presented during 2025’s conferences could affect practice, OncLive® spoke with Balazs Halmos, MD; John O. Mascarenhas, MD; Dana M. Chase, MD; and Alexander B. Olawaiye, MD.

Halmos is the associate director of Clinical Science, as well as a professor in the Departments of Oncology (Medical Oncology) and Medicine (Oncology & Hematology) at Montefiore Einstein Comprehensive Cancer Center in New York, New York. Mascarenhas is the director of the Center of Excellence for Blood Cancers and Myeloid Disorders at the Tisch Cancer Institute, and a professor of medicine at the Icahn School of Medicine at Mount Sinai in New York, New York. Chase is a professor of clinical obstetrics and gynecology in the Division of Gynecologic Oncology at UCLA Health in Los Angeles, California. Olawaiye is the vice chair for DEI, a professor in the Department of Obstetrics, Gynecology and Reproductive Sciences, and director of gynecologic cancer research at Magee-Women’s Hospital at the University of Pittsburgh Medical Center in Pennsylvania.

How did 2025 conference data affect the gynecologic oncology treatment landscape?

During the 2025 ASCO Annual Meeting, Olawaiye presented data from the phase 3 ROSELLA trial (NCT05257408), which evaluated the novel, selective GR antagonist relacorilant in combination with nab-paclitaxel (Abraxane) vs nab-paclitaxel alone in patients with PROC.¹ The dual primary end points of the study were progression-free survival (PFS) and overall survival (OS).

Findings from ROSELLA demonstrated that the study met its PFS end point; patients who received the combination (n = 188) achieved a median PFS of 6.54 months (95% CI, 5.55-7.43) compared with 5.52 months (95% CI, 3.94-5.88) for those given nab-paclitaxel monotherapy (n = 193; HR, 0.70; 95% CI, 0.54-091; log-rank P = .0076).

“ROSELLA was a major breakthrough because relacorilant is a first-in-class drug never used in cancer before,” Olawaiye explained. “[It has] a unique mode of action, [which is] very important and exciting.”

In January 2026, Corcept Therapeutics, the developer of relacorilant, announced in a news release that ROSELLA met its OS end point.² Specifically, patients in the combination arm experienced a 35% reduction in the risk of death vs those in the monotherapy arm (HR, 0.65; P = .0004). The median OS was 16.0 months and 11.9 months, respectively. Full data from the study will be shared at a future medical meeting, according to the release. Additionally, the FDA has accepted and assigned a Prescription Drug User Fee Act target action date of July 11, 2026, to a new drug application seeking the approval of relacorilant as a treatment for patients with PROC.³

Olawaiye also tabbed data from the phase 3 KEYNOTE-B96/ENGOT-ov65 trial (NCT05116189) examining pembrolizumab (Keytruda) plus paclitaxel with or without bevacizumab (Avastin) in patients with PROC, which were presented during the 2025 ESMO Congress, as particularly notable.⁴ “For the first time, we had a positive trial utilizing an immune checkpoint inhibitor for the treatment of [patients with] ovarian cancer, [which is] exciting, he commented.

Findings from the second interim analysis of KEYNOTE-B96 demonstrated that patients who received pembrolizumab plus paclitaxel with or without bevacizumab (n = 322) achieved a median PFS of 8.3 months compared with 6.4 months among those who received placebo in place of pembrolizumab (n = 321; HR, 0.73; 95% CI, 0.62-0.86). The 18-month PFS rates were 18.7% and 10.5%, respectively. In terms of the key secondary end point of OS in patients with a PD-L1 combined positive score of at least 1, those in the investigational arm experienced a 24% reduction in the risk of death compared with the placebo arm (HR, 0.76; 95% CI, 0.61-0.94; P = .0053). The median OS was 18.2 months (95% CI, 15.3-21.0) and 14.0 months (95% CI, 12.5-16.1), respectively.

In the cervical cancer space, Chase noted that findings from the phase 3 NRG Oncology/GOG-263/KGOG 1008 study (NCT01101451), which were presented in a plenary session during the 2025 SGO Annual Meeting on Women’s Cancer and subsequently published in Annals of Oncology, could be particularly informative to future practice.⁵ The study examined the addition of adjuvant chemoradiation to weekly cisplatin in patients with intermediate-risk, early-stage cervical cancer following radical hysterectomy and lymphadenectomy.

Findings from GOG-263 demonstrated that patients in the chemoradiotherapy arm (n = 155) experienced a 3-year relapse-free survival rate of 88.5% (95% CI, 82%-93%) vs 85.4% (95% CI, 79%-90%) among patients who received radiotherapy alone (n = 158; HR, 0.698; 95% CI, 0.408-1.192; log-rank 1-sided P = .09). However, the numerical difference was not statistically significant.

“Despite some of us believing that the addition of cisplatin to radiation would have improved outcomes, it actually did not,” Chase said. “For those intermediate-risk, post-operative patients with cervical cancer, adding cisplatin to their radiation does not make a difference in terms of outcomes.”

What were the most notable presentations in lung cancer?

In the lung cancer realm, Halmos highlighted data from the phase 3 CheckMate-816 study (NCT02998528) investigating neoadjuvant nivolumab (Opdivo) plus chemotherapy vs chemotherapy alone for the treatment of patients with resectable non–small cell lung cancer (NSCLC).⁶ The primary end points of the study were pathologic complete response (pCR) rate and event-free survival (EFS). OS was a key secondary end point.

At a median follow-up of 68.4 months, the median OS was not reached (NR) in the combination arm (n = 179) vs 73.7 months in the chemotherapy-only arm (n = 179; HR, 0.72; 95% CI, 0.523-0.998; P = .0479). Notably, patients who achieved a pCR in the nivolumab arm experienced a median EFS of NR compared with 27.8 months in those who did not (HR, 0.14; 95% CI, 0.06-0.33).

“We learned of these beautiful OS data at ASCO 2025,” Halmos commented. “We saw that patients who had a pCR after neoadjuvant chemoimmunotherapy have an [approximately] 95% long-term survival rate. This helps us [to determine] if those patients will require any further treatment. I thought that was practice confirming and slightly practice adjusting as well.”

Again at the 2025 ASCO Annual Meeting, investigators presented data from the phase 3 DeLLphi-304 trial (NCT05740566) of tarlatamab in second-line ES-SCLC.⁷ At a median follow-up of 11.2 months in the tarlatamab arm (n = 254) and 11.7 months in the chemotherapy arm (n = 255), the median OS was 13.6 months vs 8.3 months, respectively (HR, 0.60; 95% CI, 0.47-0.77; 2-sided P < .001). The respective 6-month OS rates were 76% and 62%, and the respective 12-month OS rates were 53% and 37%.

In November 2025, the FDA granted full approval to tarlatamab for the treatment of adult patients with ES-SCLC following disease progression on or following platinum-based chemotherapy.⁸ The approval was supported by data from DeLLphi-304.

“Tarlatamab blew second-line chemotherapy out of the water,” Halmos said. “This [can be] a tricky agent in terms of administration; inpatient use is still necessary for the first couple of treatments, and cytokine release syndrome [and] immune–associated neurotoxicity syndrome [can occur]. In reality, these are manageable adverse effects for most. With [these data], tarlatamab became the star of the show at ASCO 2025.”

Which ASH data are poised to reshape hematologic oncology?

Mascarenhas noted that data from the phase 2 PARADIGM study (NCT04801797) presented during the 2025 ASH Annual Meeting and Exposition have the potential to redefine which patients with AML are suitable candidates for venetoclax in combination with an HMA.⁹ “[PARADIGM] asked the question: ‘In patients for whom you’d typically give chemotherapy, is it really superior to give them an HMA plus venetoclax?’” he commented.

Findings from PARADIGM showed that patients who received venetoclax plus azacitidine (n = 86) achieved a median EFS of 14.6 months compared with 6.15 months with standard induction chemotherapy (n = 86; P = .0021). The respective 1-year EFS rates were 53.4% and 36.0%, respectively. In terms of OS, the median values were 21.5 months and 18.6 months, respectively (log-rank P = .1873).

“The reality is, we're already seeing a lot more use of HMA-venetoclax, even in patients [who are unfit or advanced in age], where historically we might have induced them with chemotherapy,” Mascarenhas said. “[PARADIGM] was a significant, clinically relevant [trial] that I look forward to seeing more follow-up [from]. The EFS and OS were quite exciting and got a lot of buzz.”

References

1. Olawaiye A, Gladieff L, Gilbert L, et al. ROSELLA: A phase 3 study of relacorilant in combination with nab-paclitaxel versus nab-paclitaxel monotherapy in patients with platinum-resistant ovarian cancer (GOG-3073, ENGOT-ov72). J Clin Oncol. 2025;43(suppl 17):LBA5507. doi:10.1200/JCO.2025.43.17_suppl.LBA5507
2. Overall survival primary endpoint met in Corcept’s pivotal phase 3 ROSELLA trial of relacorilant in patients with platinum-resistant ovarian cancer. News release. Corcept Therapeutics Incorporated. January 22, 2026. Accessed January 29, 2026. https://ir.corcept.com/news-releases/news-release-details/overall-survival-primary-endpoint-met-corcepts-pivotal-phase-3
3. FDA files Corcept’s new drug application for relacorilant as a treatment for patients with platinum-resistant ovarian cancer. News release. Corcept Therapeutics. September 10, 2025. Accessed January 29, 2026. https://ir.corcept.com/news-releases/news-release-details/fda-files-corcepts-new-drug-application-relacorilant-treatment-0
4. Colombo N, Zsiros E, Sebastianelli A, et al. Pembrolizumab vs placebo plus weekly paclitaxel ± bevacizumab in platinum-resistant recurrent ovarian cancer: results from the randomized double-blind phase III ENGOT-ov65/KEYNOTE-B96 study. Ann Oncol. 2025;36(suppl 2):S1582. doi:10.1016/j.annonc.2025.09.049
5. Ryu SY, Deng W, Albuquerque K, et al. Randomized phase III trial of adjuvant radiation versus chemoradiation in intermediate-risk, early-stage cervical cancer following radical hysterectomy and lymphadenectomy: results from NRG Oncology/GOG-263/KGOG 1008. Ann Oncol. 2025;36(12):1514-1524. doi:10.1016/j.annonc.2025.09.003
6. Forde PM, Spicer JD, Provencio M, et al. Overall survival with neoadjuvant nivolumab + chemotherapy in patients with resectable NSCLC in CheckMate 816. J Clin Oncol. 2025;43(suppl 17):LBA8000. doi:10.1200/JCO.2025.43.17_suppl.LBA8000
7. Rudin C, Mountzios G, Sun L, et al. Tarlatamab versus chemotherapy (CTx) as second-line (2L) treatment for small cell lung cancer (SCLC): primary analysis of Ph3 DeLLphi-304. J Clin Oncol. 2025;43(suppl 17):LBA8008. doi:10.1200/JCO.2025.43.17_suppl.LBA8008
8. FDA grants traditional approval to tarlatamab-dlle for extensive stage small cell lung cancer. FDA. November 19, 2025. Accessed January 29, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-tarlatamab-dlle-extensive-stage-small-cell-lung-cancer
9. Fathi A, Perl A, Fell G, et al. Results from paradigm - a phase 2 randomized multi-center study comparing azacitidine and venetoclax to conventional induction chemotherapy for newly diagnosed fit adults with acute myeloid leukemia. Blood. 2025;146(suppl1):6. doi:10.1182/blood-2025-6