GSK secures expanded TGA nod in endometrial cancer

The Therapeutic Goods Administration (TGA) has granted approval for GSK’s anti-PD-1 immunotherapy, Jemperli (dostarlimab), in combination with chemotherapy (carboplatin and paclitaxel) for adult patients with primary advanced or recurrent endometrial cancer with mismatch repair proficient (MMRp) status.

This regulatory milestone marks an expansion of treatment options for a cancer type where progress has stubbornly lagged.

“We welcome the availability of additional treatment options for all eligible women diagnosed with this challenging gynaecological cancer,” said Professor Linda Mileshkin, Director of Medical Oncology at Peter MacCallum Cancer Centre. “Sadly, we see the incidence of this cancer is rising, and at the same time, endometrial cancer is one of few cancers where survival rates are decreasing.”

She added, “While we don’t fully understand what’s driving this, it seems lifestyle factors, including rising rates of obesity in the community, play a role. Providing eligible Australian women with access to innovative medicines is critical to improving patient outcomes.”

The approval is underpinned by data from the phase 3 RUBY trial (part one), in which Jemperli combined with chemotherapy reduced the risk of death by 31% compared to chemotherapy alone, regardless of biomarker status. Within the MMRp subgroup, death risk was reduced by 21%, although this did not reach statistical significance. Importantly, median overall survival increased to 34 months in the Jemperli group, versus 27 months with chemotherapy alone.

For patient advocates, the focus now shifts to broader and equitable access.

“This new TGA indication for Jemperli is an important step toward greater access for patients, however, a PBS listing is the ideal outcome,” said Christine Cockburn, CEO of Rare Cancers Australia. “For too long, progress and treatment developments in gynaecological cancers have lagged behind other, more common cancers, and this inequity needs to change.”

Endometrial cancer remains Australia’s most common reproductive cancer, with more than 50 women diagnosed each week. Around 20% are diagnosed at an advanced stage, and among these, only one in five survive beyond five years – a stark reminder of the need for innovation and timely access.

Jemperli was first approved by the TGA last year, followed by PBS listing for approximately 20–30% of women with advanced or recurrent endometrial cancer who have the mismatch repair deficient (dMMR) biomarker. The latest approval broadens the eligible population by including MMRp patients.

“At GSK, endometrial cancer is a vital focus of our work in gynaecological cancers,” said Andrew Thomas, VP and General Manager of GSK Australia. “We remain committed to providing innovative treatment options to support better outcomes for women living with this life-threatening condition.”

Looking ahead, the second part of GSK’s RUBY trial is evaluating the combination of Jemperli and PARP inhibitor Zejula (niraparib), with early signals suggesting stronger progression-free survival than Jemperli alone. Long-term overall survival data is still pending.

Meanwhile, AstraZeneca is pursuing a similar strategy in the phase 3 DUO-E trial, combining PD-L1 inhibitor Imfinzi (durvalumab) with PARP inhibitor Lynparza (olaparib).

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