SABCS roundup: Novartis shows two-year PFS in breast cancer subgroups; AstraZeneca reveals more Enhertu data
The San Antonio Breast Cancer Symposium is taking place this week, and so far, some of the Big Pharmas are turning out new trial data about some of the biggest drugs in the space.
First off, Novartis announced that its drug, Kisqali, showed about a year of progression-free survival in patients with different types of first-line metastatic breast cancer. The CDK 4/6 drug was first approved by the FDA in 2017, setting it up in direct competition against Pfizer’s Ibrance.
The Phase II study, studying 222 patients with different forms of HR+/HER2- cancers, showed that Kisqali plus endocrine therapy doubled median progression-free survival compared with combination chemotherapy. The chemotherapy had a median progression-free survival at 12.3 months, while Kisqali plus endocrine therapy showed a 24-month median. The trial also reported a p-value of p=0.0007.
Novartis said the rest of the data will come as a late-breaking oral presentation closer to the end of the conference.
AstraZeneca, Daiichi tout updated OS data in HER2+
Just a few months after AstraZeneca and Daiichi Sankyo presented data from the DESTINY-Breast04 trial, beating out chemotherapy in HER2-low patients to such an extent that Jefferies analysts called Enhertu “the gospel” for breast cancer patients, the pair is back with more data.
Updated results from the DESTINY-Breast03 trial tested the antibody-drug conjugate, or ADC, in patients with previously treated HER2-positive unresectable and/or metastatic breast cancer. The therapy, approved by the FDA earlier this year, showed a statistically significant improvement in overall survival compared to T-DM1, another antibody-drug conjugate therapy that’s sold by Roche as Kadcyla.
More specifically, the therapy showed a 36% reduction in risk of death, per a secondary endpoint analysis that puts a p-value at p=0.0037. After two years of follow up, 77.4% of patients in the Enhertu arm were estimated to still be alive — compared to just under 70% on those treated with T-DM1.
The next-gen drug started attracting more and more attention last year, thanks to a readout at #ESMO21 that showed Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, per interim data at the time.
Primary results from another Enhertu trial, the DESTINY-Breast02 trial, were to be presented today at the conference, per a statement from the duo.
Gilead reports improved response, survival in PhIII Trodelvy analysis
Gilead is looking to expand its Trop-2 targeted ADC Trodelvy into the HER2 cancer space, and it’s touting some new data to support that move.
Taken from a post-hoc analysis of the Phase III TROPiCS-02 trial looking at Trodelvy versus a comparator chemotherapy, data showed that Trodelvy improved progression-free survival, overall survival and objective response rates in patients compared to physician’s choice of chemotherapy across expression levels of the Trop-2 protein. The study was done in patients with HR+/HER2- metastatic breast cancer who progressed on endocrine-based therapies and at least two chemotherapies.
The company said that more details will be presented later at the conference.
While Trodelvy is an approved therapy already, it has not been approved in HR+ or HER2- metastatic breast cancer yet. However, the FDA accepted an sBLA earlier this year under Priority Review — and the PDUFA date is currently set for sometime in February.
Earlier this year, Gilead said at #ESMO22 that a second interim analysis of TROPiCS-02 showed improved overall survival in patients with HR+/HER2- metastatic breast cancer in a statistically significant and “clinically meaningful” way. However, Jefferies analyst Michael Yee pointed out at the time that based on previous analyses, “GILD has also stated the OS data are clinically meaningful which may imply the result is probably not below 2-3mos based on our interpretation and prior datapoints.”
Eli Lilly reports updated results from pivotal Verzenio trial
Eli Lilly updated results from a pivotal Phase III called monarchE, testing adjuvant Verzenio with endocrine therapy in patients with HR+, HER2- high risk early breast cancer. That data showed an increase in both invasive disease-free survival (IDFS), as well as distance relapse-free survival (DRFS).
Per the Big Pharma, the analysis shows a median follow-up period of 3.5 years, noting that all patients either completed or discontinued a two-year treatment period on the drug.
Lilly said that the increase in those two metrics continued to get better at the four-year mark, noting 6.4% and 5.9% in IDFS and DRFS, respectively — and showing improvements from previously-recorded two and three-year rates in all prespecified subgroups. The two year rates in the groups was 2.8% and 2.5%.
However, the pharma did note that OS data “remain immature at this time.”
The monarchE trial, which enrolled more than 5,600 patients overall, showed that the risk of developing “invasive disease” in an ITT population was reduced by just over 33%, with a p-value of p<0.0001. Additionally, Verzenio reduced the risk of developing metastatic disease by 34.1%, also with a p-value of p<0.0001.