Genmab — Oktober 2020

[E_L]

The usual positive comments on Dara, but also on amivantamab

[E_L]

"As we head into the fourth quarter, we look forward to additional planned submissions, most notably our U.S. filing of our BCMA CAR-T in multiple myeloma as well as the U.S. filing for amivantamab in non-small cell lung cancer.

[E_L]

I would also point to some of the filings that we anticipate here in the near-term with respect to the CAR-T BCMA as well as amivantamab for non-small cell lung cancer, potentially on the horizon and part of the mix in 2021.

[E_L]

-Maybe I can take the question on the EGFR-cMet antibody amivantamab. It is a really exciting project for us. You asked about near-term and long-term. First on the antibody itself, it's a really interesting antibody. It's unique to us and it incorporates both EGFR binding peak and the CMS binding peak and CMS is common resistance mechanism for EGFR therapy. So it's both the primary mutation and the resistance mechanism at the same time.

[E_L]

The near-term plan is to go forward with an Exon 20 EGFR tumor, non-small cell lung cancer, there are really no good opportunities for patients with Exon 20 signatures. But that's how we will begin but our eyes are on the larger EGFR mutation market and patients in non-small lung cancer. So with time, we plan on exploring multiple lines of therapy and eventually all EGFR containing tumors."

[E_L]

JNJ pipeline https://www.investor.jnj.com/_document/jnj-pipeline-q3-2020?id=00000175-21bf-d7ee-a9fd-39bfc4380000

[Sukkeralf]

anything about filing for approval this year with amivantamab or anything about the new Duobody in the clinic?

[E_L]

I think 10:50 points to amivantamab filing in Q4?

[E_L]

Beyond that i can only find JNJ-7957 (BCMA/CD3), JNJ-7564 (GPRC5D/CD3) for planned filing 2020-2023

[Sukkeralf]

10:50 E L - ohh yes sorry !

[Bulder]

Thx E L

[Bulder]

I didn't realize we were that close to an amivantamab filing.

[Sukkeralf]

Its going to be fun to see milestones for filing and approval to get a feeling about how backloaded these Duobody deals are

[bongobob]

Meget informativt om Amivantamab. 6-12 md approval...moving to 1.line... Beklager hvis den har været linket. https://www.docwirenews.com/hematology-oncology/amivantamab-plus-lazertinib-combo-show-promising-results-at-esmo-2020/

[E_L]

SITC ID: 561
DuoBody-PD-L1×4-1BB (GEN1046) induces superior immune-cell activation, cytokine production and cytotoxicity by combining PD-L1 blockade with conditional 4-1BB co-stimulation https://sitc.planion.com/Web.User/AbstractDet?ACCOUNT=SITC&ABSID=13906&CONF=SITC20&ssoOverride=OFF&CKEY=

[GeorgeBest]

Thanks E L and bongobob

[E_L]

SITC ID: 412
First-in-human phase I/IIa trial to evaluate the safety and initial clinical activity of DuoBody-PD-L1×4-1BB (GEN1046) in patients with advanced solid tumors https://sitc.planion.com/Web.User/AbstractDet?ACCOUNT=SITC&ABSID=13347&CONF=SITC20&ssoOverride=OFF&CKEY=

[GeorgeBest]

12:40 I like the phrase “superior”

[E_L]

Conclusions DuoBody-PD-L1×4-1BB demonstrated biologic activity and a manageable safety profile. Encouraging early clinical activity across different dose levels was observed in a heavily pretreated population with advanced solid tumors, including those resistant to prior immunotherapy or typically less sensitive to ICIs. Expansion cohorts of patients for whom DuoBody-PD-L1×4-1BB treatment could be relevant and biologically sound have started enrollment. Updated data will be presented.

[E_L]

Disease control, including stable disease at first assessment and partial responses in triple-negative breast cancer, ovarian cancer, and immune checkpoint inhibitor (ICI)–pretreated NSCLC, occurred in 40/61 patients (65.6%).