GSK plc's Q2 2026 earnings call, held on July 28, outlined one of the company's most aggressive late-stage pipeline acceleration programs, with more than 20 Phase III trial starts expected in 2026—up from 10 previously planned. The expansion will be supported by Accelerate Growth, a three-year program targeting GBP 1.9 billion (USD 2.5 billion) in annual savings by 2029, the majority of which GSK plans to reinvest in its late-stage pipeline. The call was dominated by oncology ADC momentum, a significant respiratory pipeline expansion, and the strategic integration of the recently closed Nuvalent acquisition.
Sales grew 5% to more than GBP 8.4 billion in Q2, with core operating profit up 7% and core earnings per share up 9%. GSK reaffirmed its full-year guidance ranges but said sales and core operating profit were now expected in the upper half of their respective ranges, while core EPS was expected in the lower half following the GBP 7.1 billion net cost of the Nuvalent acquisition.
Management said the accelerated development program stems from a new portfolio review process launched earlier this year, in which senior executives review late-stage assets every two weeks to identify opportunities to compress development timelines. The review has led to acceleration decisions across 7 assets, 18 indications, and 25 studies, more than doubling planned Phase III trial initiations in 2026 from 10 to more than 20. GSK said the expanded development effort will be funded through a new GBP 1.9 billion cost-reallocation program, which will redirect spending toward late-stage R&D while supporting growth through the anticipated loss of dolutegravir exclusivity.
Mo-Rez: Five Phase III studies planned or initiated in 2026
GSK's B7-H4-directed ADC mocertatug rezetecan (Mo-rez) has moved from Phase Ib to Phase III initiation in just 15 months, with five pivotal studies planned or initiated across ovarian and endometrial cancer. More than 600 patients had been dosed across the Mo-Rez clinical program as of July 22, according to GSK. Hesham Abdullah, GSK's Senior VP and Global Head of Oncology R&D, cited a 62% response rate in platinum-resistant ovarian cancer and 67% in second-line-plus endometrial cancer, with activity described as independent of B7-H4 expression level and without TROP-2-specific stomatitis. Management said further safety and efficacy data from Mo-rez would be presented at ESMO. The competitive context is significant: multiple TROP-2-directed ADCs are already approved or in late-stage development in gynecological cancers, and GSK is explicitly positioning Mo-rez's linker-payload technology as potentially differentiated on both efficacy and tolerability.
Ris-rez: First positive Phase III OS data for B7-H3 ADC
GSK's B7-H3-directed ADC, risvutatug rezetecan (Ris-rez), achieved a milestone that management described as the first positive Phase III overall survival data for any B7-H3-directed ADC in any tumor type, following partner Hansoh's announcement that the Artemis-008 Phase III study conducted in China in second-line small cell lung cancer met its primary OS endpoint. Hansoh also reported that the China Phase III ARTEMIS-011 study met its primary endpoint of IRC-assessed PFS in relapsed osteosarcoma, a tumor type where Ris-rez holds FDA breakthrough therapy designation. GSK's own global Phase III study, EMBOLD Small Cell Lung Cancer 301, is actively recruiting in the second-line setting, with a first-line study planned to initiate later in 2026. In prostate cancer, GSK said it would initiate three Phase III studies before year-end: two monotherapy studies in late-line and chemo-naive metastatic castrate-resistant prostate cancer, and one combination study in metastatic hormone-sensitive prostate cancer, supported by a 37% confirmed objective response rate and 56% nine-month landmark PFS rate in mCRPC. Abdullah described Ris-rez as "effectively an oncology pipeline in a single asset." The primary competitors in B7-H3-directed ADCs include assets from Daiichi Sankyo and others, though management indicated that GSK's combination of Hansoh-derived data volume, a combined clinical dataset encompassing more than 930 patients across studies, and translational biomarker strategy may provide differentiation in patient selection.
Ultra-long-acting TSLP (GSK'283): Six Phase III studies to start by end-'26
GSK's 6-monthly anti-TSLP biologic, GSK5784283, has been accelerated by 9 months across three indications — asthma, nasal polyps, and COPD — with 6 pivotal Phase III studies (the PERSIST program) now planned to start by year-end. Kaivan Khavandi, GSK's Head of Respiratory, Immunology, and Inflammation R&D, said interim pharmacodynamic data from the GSK-sponsored Phase II NASER study in asthma, combined with data from partner Hengrui in nasal polyps, provided sufficient confidence to submit all three Phase III indications under the IND and to hold end-of-Phase II discussions with regulators. Management explicitly acknowledged competitive pressure from Generate Bio as a factor accelerating the timeline decision. Khavandi said the COPD pivotal study would enrich for patients with intermediate-to-high T2 inflammation, conceding that the mechanism is not expected to work in T2-low COPD — a population that GSK is separately targeting with its anti-IL-33 program. AstraZeneca and Amgen's tezepelumab (Tezspire) is the established TSLP competitor in asthma and nasal polyps, though no approved ultra-long-acting TSLP exists.