The best of the rest: Highlights from the below-the-fold presentations at #ESMO21
This year’s ESMO Congress has had a major focus on Big Pharma drugs — most notably candidates from Merck and AstraZeneca — but there have also been updates from smaller biotechs with data looking to challenge the big-name drugmakers.
Today, we’re highlighting some of the data releases that flew under the radar at #ESMO21 — whether from early-stage drugs looking to make a mark or older stalwarts with interesting follow-up data.
Here’s the best of the rest:
Agenus highlights PD-1/CTLA-4 data in advanced cervical cancer
Agenus on Sunday presented final results from its Phase II C-550 study showing a combination of its balstilimab and zalifrelimab posted a response rate of 26% in patients with second-line recurrent or metastatic cervical cancer.
The PD-1/CTLA-4 combo reported 10 complete responses and 22 partial responses among the study’s modified 125-patient pool. Meanwhile, the combination performed particularly well in PD-(L)1 positive patients, with a 32.8% response rate among 67 patients, who made up the majority of the study’s population.
At a six-month check-in, 86.5% of responders were still responding to treatment with combo, while at one year that number declined to 64.2%. Meanwhile the combo posted a median overall survival of 12.8 months at a median 21-month check-in and a PFS of 2.7 months. For the PD-(L)1 positive cohort, median OS was 15.7 months.
Agenus called this study group the largest to show benefit for PD-1/CTLA-4 blockade in recurrent or metastatic cervical cancer, taking a shot right at Bristol Myers Squibb’s combo of Opdivo and Yervoy, which turned out data in this population back in 2019. In the CHECKMATE-358 Phase II study, Opdivo-Yervoy posted a response rate of 26.3% among 19 patients with five complete and partial responses.
Regeneron’s Libtayo looks to match Keytruda’s combo approval in 1L lung cancer
Regeneron’s Libtayo in combination with chemotherapy aced its survival endpoints as part of the Phase III EMPOWER-Lung-3 study in first-line patients with metastatic non-small cell lung cancer, with data that look very similar to what a Keytruda-chemo combo has already posted there.
Libtayo-chemo hit a median OS of 22 months with a median progression-free survival of 8 months, reducing the relative risk of death by 29% compared with a chemo regimen alone. Meanwhile, the combo posted a 43% response rate compared with 23% for chemo and a 16-month duration of response versus seven months for chemo.
But Keytruda has the headstart here, with data from the KEYNOTE-189 study showing largely the same efficacy numbers. The FDA granted the Keytruda-chemo combo an approval here back in August 2018, adding to its approval as a solo agent in the same setting.
Seagen, Genmab roll out combo data for ADC in cervical cancer
Speaking of cervical cancer, Seagen and Genmab have new data out on their investigational antibody-drug conjugate tisotumab vedotin (TV) showing some strong results in combination with the chemotherapy carboplatin or Keytruda across multiple lines of therapy for recurrent or metastatic patients.
According to cohort data from the Phase Ib/II innovaTV 205 study, the TV-carbo combo posted a response rate of 55%, including four complete responses and 14 partial responses, in first-line recurrent or metastatic cervical cancer patients. At a median follow-up of 7.9 months, the combo’s duration of response was 8.3 months with a median progression-free survival of 9.5 months.
Meanwhile, a combination of TV and Keytruda in second- or third-line cervical cancer patients posted a 38% response rate in 34 patients, with two complete responses and 11 partial responses reported. You’ll remember the Phase II KEYNOTE-158 study from a couple years ago posted a 17% response rate for solo Keytruda in previously treated advanced cervical cancer, potentially pointing to some benefit for TV as part of the combo.
“As we advance our clinical development program for tisotumab vedotin into earlier lines of therapy in cervical cancer, we’re encouraged by these interim results of the combination cohorts with tisotumab vedotin,” Seagen CMO Roger Dansey said in a statement. “Based on these results from the innovaTV 205 study, we also plan to evaluate tisotumab vedotin further in various combinations in first-line metastatic or recurrent cervical cancer.”
Merck backs up recent Keytruda approval in TNBC with OS win
A combination of Keytruda and chemotherapy reduced the risk of death by 27% over chemo alone (p=0.0093) in first-line patients with PD-(L)1 expressing triple-negative breast cancer, according to data presented Sunday.
The complete OS results come as a backstop for the FDA’s accelerated nod in this indication back in November, which was upgraded to a full approval in July.
The combination posted a median OS of 23 months compared with 16.1 months for chemo. The agency based its approval on data from the KEYNOTE-355 study, which showed the combo reduced the risk of disease progression or death by 35% with a median PFS of 9.7 months, against 5.6 months in the chemo arm.
Novartis’ Kisqali gets long-awaited OS readout in HR+/HER2- breast cancer
After waiting nearly five years for the data to mature, Novartis can now tout an OS win for its CDK 4/6 inhibitor in first-line advanced HR+/HER2- breast cancer, the Swiss drugmaker said Sunday.
At a whopping 63.9-month follow-up, Kisqali combined with the aromatase inhibitor letrozole posted a median OS of 63.9 months compared with 51.4 months for letrozole alone — a more than one-year OS benefit. Novartis is calling the OS readout the longest for a CDK 4/6 and a boon for patients after a very long wait for final results.
The data come from the MONALEESA-2 trial, which was the basis for Novartis’ initial approval in this indication way back in 2017.