Guessing which of the thousands of Asco presentations will be the biggest news of the meeting is a mug’s game, but the abstracts released in advance of the world’s biggest oncology conference give the sector an idea of which ones will be important.
Results from Roche’s Aphinity trial of Perjeta in the extended adjuvant breast cancer setting will surely be a huge catalyst, as they will go a long way to predicting the future of Puma’s rival neratinib – breast cancer will also figure prominently in presentations for Astrazeneca’s Lynparza, Abbvie’s veliparib and Eli Lilly’s abemaciclib. Next-generation checkpoint inhibition will also take the spotlight, with numerous readouts of trials with Incyte’s epacadostat, along with candidates acting on LAG3, GITR and ICOS.
Roche has already given a sneak peek at Aphinity’s results, disclosing a statistically significant benefit on invasive disease free survival (iDFS) when Perjeta and Herceptin are taken together for a year vs Herceptin alone (Aphinity all but confirms Puma’s worst nightmare, March 2, 2017). The Swiss group kept the key data secret for high-profile disclosure at Asco, so oncologists will be eager to see full details at a late-breaking session on Monday, June 5.
So will Puma executives, who will look for any weakness to give them some hope that the FDA will see that a year of neratinib following Herceptin offers a clinical benefit (Upcoming events – Panel woes for Puma and statistical uncertainties for Emmaus, May 12, 2017).
In this instance, Roche and Puma are fighting over the adjuvant setting, which aims to prevent recurrence following successful interventions. There is much improvement to be made in treating advanced and metastatic breast cancer, which is where Parp inhibitors from Astrazeneca, Pfizer and Abbvie will feature along with CDK 4/6 inhibitors from Eli Lilly and Novartis.
|Asco readouts to watch|
|Perjeta||Roche, Puma||Aphinity, late breaker||LBA500|
|Abemaciclib||Eli Lilly, Novartis, Pfizer||Monarch 2||1000|
|Lynparza||Astrazeneca, Abbvie, Tesaro, Pfizer||Olympiad trial||LBA4|
|Veliparib||Abbvie, Astrazeneca, Tesaro, Pfizer||PIII triple negative breast cancer||520|
|Talazoparib||Pfizer, Astrazeneca, Abbvie, Tesaro||Abrazo trial||1007|
|Keytruda + epacadostat||Incyte, Merck & Co||Breast, ovarian patients from Keynote-037/Echo-202 trial||1103|
|Renal cell carcinoma patients from Keynote-037/Echo-202||4515|
|Head and neck cancer patients from Keynote-037/Echo-202||6010|
|NSCLC patients from Keynote-037/Echo-202||9014|
|Durvalumab + tremelimumab||Astrazeneca||Durvalumab + tremelimumab in breast cancer||3052|
|Opdivo||Bristol-Myers Squibb||Opdivo + epacadostat in solid tumours||3003|
|Opdivo + BMS-986156 in solid tumours||104|
|Opdivo + BMS-986016 in melanoma||9520|
|Bristol-Myers Squibb, Jounce||Opdivo + JTX-2011||3033|
The advance publication of the Monarch 2 data shows a 16.4 month progression free survival for HR+/Her2- advanced breast cancer patients who progressed on (neo)adjuvant endocrine therapy when they took Lilly’s CDK inhibitor abemaciclib plus fulvestrant, a statistically significant benefit over the 9.3 months in patients who took fulvestrant plus placebo alone.
Leerink analyst Seamus Fernandez wrote that the Monarch 2 data confirm that abemaciclib will be competitive with Pfizer’s first-to-market Ibrance and Novartis’s Kisqali, but its position will be more clearly defined by data from Monarch 3, stopped early for efficacy and likely to be presented at an autumn cancer meeting in Europe (Snippet roundup: A new PD-L1 is born, and success for Newron at long last, March 24, 2017).
The Parp inhibitors, of course, are trying not to be overshadowed in breast cancer, and Astrazeneca will have late-breaking data from the Olympiad trial on Sunday, June 4. This trial tested Lynparza against chemotherapy in patients with an Her2-negative metastatic breast cancer (mBC) and a germline BRCA mutation.
Abbvie, of course, was forced to announce failure of its Parp inhibitor veliparib in triple negative breast cancer after abstracts were accidently put online. And in that hard to treat indication, Pfizer has response data for its Parp, talazoparib, from the phase II Abrazo study.
The breast cancer space will see a big push from immuno-oncology agents, which so far have been focused in such diseases as melanoma and lung cancer. Merck & Co and Incyte will be unveiling data from several cohorts of the Keynote-037/Echo-202 trial, including one in triple negative breast cancer and ovarian disease. In this heavily pre-treated population, the combination achieved an objective response rate of 10% and a disease control rate of 36% in breast cancer and 8% and 35% respectively in ovarian cancer.
Merck is not alone in pressing immunotherapy into breast cancer. Astrazeneca will feature data from its durvalumab-tremelimumab combination in a small breast cancer study, in which it found a 71% clinical benefit rate in triple negative disease, along with data from chemo combos.
Outside of breast cancer, Keynote-037 will also reveal data in renal cell carcinoma, head and neck cancer, and non-small cell lung cancer – in the last of these researchers detected a 35% objective response rate and a 60% disease control rate.
Bristol-Myers Squibb will be taking combinations of Opdivo with next-generation immuno-oncology agents to Asco. The group will have early data in solid tumours in combination with epacadostat – the pairing has impressive response and disease control rates in head and neck cancer and melanoma.
In-house checkpoint inhibitors BMS-986156, a GITR agonist, and BMS-986016, an anti-LAG3, are the subject of combination studies with Opdivo. Abstracts for both reveal early data, but it seems likely researchers should be able to provide updated results. Bristol will also feature an Opdivo combination with Jounce Therapeutics’s JTX-2011, an ICOS-blocking antibody.
The advance publication of abstracts as usual allows investors to make trading decisions today. There will no doubt be more valuation-shifting surprises after the curtain raises in Chicago.